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Comparing the Effects of Levobupivacaine and Bupivacaine in Saddle Spinal Anesthesia

Primary Purpose

Outpatients, General Surgery, Anorectal Disorder

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levobupivacaine (as Levobupivacaine Hydrochloride) 75 Mg/10 mL Solution for Injection Ampoule
Bupivacaine/Dextrose
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Outpatients focused on measuring Saddle block, Hyperbaric levobupivacaine and bupivacaine, Outpatient anorectal surgery

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-II risk group with planned elective anorectal surgery
  • Approved to participate in the study and spinal anesthesia

Exclusion Criteria:

  • Known hypersensitivity to amid-type local anesthetics
  • Not to accept regional anesthesia administration
  • With preoperative motor and sensory loss
  • Not to accept participation in the study
  • Contraindications for spinal anesthesia method

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group L (Hyperbaric Levobupivacaine)

    Group B (Hyperbaric Bupivacaine)

    Arm Description

    7,5 mg (1.5 mL) of 0,5% hyperbaric levobupivacaine injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. In order to obtain hyperbaric levobupivacaine, 1 mL 0.75% isobaric levobupivacaine (Chirocaine® 75 mg/10mL ampoule Abbott/Turkey, Nycomed Pharma/Norway) was added to 0.24 mL 50% Dextrose (dextrose 120 mg) (Eczacıbaşı/Turkey) and 0.26 mL distilled water.

    7,5 mg (1.5 mL) of 0,5% hyperbaric bupivacaine (Marcaine® Spinal Heavy, 0.5%, 4 mL ampoule, AstraZeneca/England, Eczacıbaşı/Turkey, dextrose content 80 mg/mL) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds.

    Outcomes

    Primary Outcome Measures

    Adequate level of anesthesia for surgery
    The time until the needle tip is not felt in all sacral dermatomes with "pin prick" test at determined time intervals after spinal anesthesia.
    Time to obtain maximum sensory block
    The time which the highest level of dermatome is formed when the needle tip is not felt with the "pin prick" test at the specified time intervals.
    The highest level of sensory block
    The highest dermatome level where the needle tip is not felt pointed with the "pin prick" test at the specified time intervals.
    Two segment regression time of sensory block
    The time from the maximum sensory block level obtained to two segment regression
    The end time of sensory block
    The time from sensory block start time until sensory block is removed in all dermatomes assessed by pin prick test.
    The degree of maximum motor block
    With 3 points in modified Bromage score (3= lower extremities cannot be moved).
    The time to obtain maximum motor block degree
    The time until the maximum level of motor block with 3 points in modified Bromage score (3= lower extremities cannot be moved) after spinal anesthesia.
    The end time of motor block
    Time from motor block start time until the modified Bromage score returns to 0 again.

    Secondary Outcome Measures

    Heart rate
    Heart rate as beats/minute
    Systolic arterial pressure
    Non-invasive measurement of systolic arterial pressure (mmHg)
    Diastolic arterial pressure
    Non-invasive measurement of diastolic arterial pressure (mmHg)
    Mean arterial pressure
    Non-invasive measurement of mean arterial pressure (mmHg). To calculate a mean arterial pressure, double the diastolic blood pressure and add the sum to the systolic blood pressure. Then divide by 3.
    Peripheral oxygen saturation - SpO2
    Non-invasive measurement of SpO2 (%).
    First analgesic requirement
    The time that severity of pain measured using Verbal Numerical Scale (0= no pain, 10= most severe pain possible) above 4 points.
    First mobilization time
    The first time the patient can mobilize in postoperative period
    First voiding time
    The first time the patient can urinate in postoperative period
    Patient satisfaction
    Degree of satisfaction was recorded on a 5-point scale as 0 poor, 1 fair, 2 good, 3 very good and 4 perfect.
    Surgeon satisfaction
    Degree of satisfaction was recorded on a 5-point scale as 0 poor, 1 fair, 2 good, 3 very good and 4 perfect.

    Full Information

    First Posted
    January 20, 2020
    Last Updated
    January 26, 2020
    Sponsor
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04245774
    Brief Title
    Comparing the Effects of Levobupivacaine and Bupivacaine in Saddle Spinal Anesthesia
    Official Title
    Comparing the Effects of Levobupivacaine and Bupivacaine in Anorectal Surgery Under Saddle Spinal Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 21, 2007 (Actual)
    Primary Completion Date
    August 13, 2008 (Actual)
    Study Completion Date
    December 17, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gazi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    İn this study; it was aimed to investigate the effects of equipotent doses of hyperbaric bupivacaine and hyperbaric levobupivacaine in outpatient anorectal surgery under saddle block. Sixty patients between the age of 18- 50 and in the risk group of ASA I-II included in the study. 7,5 mg of 0,5% hyperbaric bupivacaine or 7,5 mg of 0,5% hyperbaric levobupivacaine injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife. Hemodynamic parameters like NIBP, HR, SpO2, sensory and motor block characteristics, duration of analgesia, time of first voiding, mobilization time, patient and surgeon satisfaction, adverse effects and discharge time were recorded during and after surgery.
    Detailed Description
    This study was completed in the General Surgery operating room within the Department of Anesthesiology and Reanimation in Gazi University Faculty of Medicine after receiving permission from Gazi University, Faculty of Medicine Local Ethics Committee (dated 28.05.2007, numbered 172). After receiving informed consent forms, the study included 60 patients aged 18-50 years in ASA I-II risk group with planned elective anorectal surgery. Those with known hypersensitivity to amid-type local anesthetics, who did not accept regional anesthesia administration, with preoperative motor and sensory loss, who did not accept participation in the study and with contraindications for spinal anesthesia method were not included in the study. Patients did not have premedication before the operation. Patients were divided into two groups with Group B given 7.5 mg (1.5 mL) hyperbaric bupivacaine (Marcaine® Spinal Heavy, 0.5%, 4 mL ampoule, AstraZeneca/England, Eczacıbaşı/Turkey, dextrose content 80 mg/mL), while Group L were administered 7.5 mg (1.5 mL) hyperbaric levobupivacaine. In order to obtain hyperbaric levobupivacaine, 1 mL 0.75% isobaric levobupivacaine (Chirocaine® 75 mg/10mL ampoule Abbott/Turkey, Nycomed Pharma/Norway) was added to 0.24 mL 50% Dextrose (dextrose 120 mg) (Eczacıbaşı/Turkey) and 0.26 mL distilled water. While mixing hyperbaric levobupivacaine, in order to obtain accurate doses of levobupivacaine, it was measured with 50% dextrose and 1 mL distilled water in an insulin injector. The hyperbaric bupivacaine and hyperbaric levobupivacaine had specific gravity values measured in Gazi University, Central Biochemistry Laboratory (solutions were heated before measurements and set with an electronic thermometer - Microlife gold-tipped thermometer MT 3001, importer Trimpeks - İstanbul, Made in P.R.C.) at 37 ºC as 1.026 (URISYS 2400, Serial No:1744-017 part No:614-0010, Roche Diagnostics Germany, Made in Japan Production year 2005). Based on specific gravity, mean density in water at 37 ºC was accepted as 0.993 g/mL (51,72) and we calculated the solution density used in our study as 1.0188 g/mL (1.026 x 0.993 g/mL = 1.0188 g/mL). Local anesthetics to be used for spinal anesthesia were prepared by another anesthesiologist so the researcher who would administer and monitor the patient, and the patient, did not know which was used. Sixty patients had the random double-blind study method applied according to order until each group contained 30 patients. Before administering spinal anesthesia, IV cannulation was performed on the nondominant hand with an 18-gauge (G) branule and patients were administered 8-10 mL/kg Ringer lactate solution over 10-15 minutes. The fluid amounts before anesthesia and in total were recorded. Patients taken to the operating room had ECG (II derivation), SpO2, and noninvasive blood pressure (NIBP) monitoring performed (NIHON KOHDEN, Model: BSM4113K, SN:01236, 2004 - Japan). The 4 L/min O2began to be administered through a mask and basal hemodynamic parameters for patients with preoperative motor and sensory examination were recorded as control values on the monitoring form prepared for the study. All patients had spinal anesthesia performed in the sitting position in the L4-5 or L5-S1 interspinous space. The number of spinal puncture attempts and the successful interval were recorded. If puncture was unsuccessful on the third attempt, the case was excluded from the study. All drugs were prepared for single use under sterile conditions. After necessary skin disinfection, the interval for the intervention had local anesthesia provided by 2 mL 2% lidocaine administered with a 22 G fine needle to infiltrate the ligamentum flavum from the skin. The appropriate interval first had a 20 G 35 mm needle introducer (guide needle) inserted from the spinal needle set. Within the introducer, a 26 G atraumatic spinal needle (Atraucan®, B.Braun, Melsungen AG) was inserted parallel to the dura fibers on the midline until the dura was passed and then the chuck of the spinal needle was removed and after clear cerebrospinal fluid (CSF) was observed the needle opening was turned toward sacral. For Group B 7.5 mg hyperbaric bupivacaine (1.5 mL) and for Group L 7.5 mg (1.5 mL) hyperbaric levobupivacaine was administered into the intrathecal space over 30 seconds and the end of drug administration was accepted as 0 minutes. Supported by an assistant, the patients were left in sitting position for 5 min and then laid supine. The break region of the operating table was placed equivalent to the iliac crista of the patient and they were given the prone jack-knife position. Spinal anesthesia sensory block level, motor block degree and hemodynamic markers of heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP) and SpO2values were recorded every 2.5 min until 15 min after spinal anesthesia and later every 5 min until the end of surgery. Sensory block level was assessed using a blunt-tipped needle with the 'pin prick' test by touching appropriate dermatome on the standard dermatome map; sympathetic block degree was measured with the feeling of temperature on the skin by touching with cold alcohol sponge; and motor block level was assessed with the modified Bromage scale (0= no paralysis, thighs, legs and feet can be raised, 1= thighs cannot be moved, knees moved, 2= knees cannot be moved, ankles can be moved, 3= lower extremities cannot be moved). After identifying that all sacral dermatome could not feel the tip of the needle, the operation was allowed to begin. The duration from puncture to beginning of operation was recorded. With the 'pin prick' test, the region of surgery was checked for sufficient sensory block for analgesia. Sensory block was recorded and evaluated as the duration sensory block continued before regression to two dermatome. Sensory and motor block assessments were performed during the operation. The duration to form sufficient anesthesia for the relevant surgery, time when maximum levels were reached, maximum level, time for sensory block to regress two segments and end time for sensory block were recorded. For motor block, maximum motor block degree and formation duration, and end time for motor block were assessed and recorded. If sufficient anesthesia was not provided 20 min after administration of spinal anesthesia, the case was excluded from the study and general anesthesia was planned. MAP falling more than 20% according to control values or below 60 mmHg was accepted as hypotension, and rapid fluid replacement began (50 mL/min). If there was no response within three minutes, IV bolus 5 mg ephedrine (Ephedrine HCl ampoule, 0.05 g, 1 mL OSEL/İstanbul) was administered and total ephedrine amounts before being sent to the ward were recorded. If HR fell below 50 beats/min, it was evaluated as bradycardia and IV bolus 0.5 mg atropine (atropine sulfate, ½ mg, 1 mL ampoule, OSEL/İstanbul) was administered and it was recorded on the monitoring form. Patients were monitored for side effects like hypotension, bradycardia, nausea, vomiting, pain, shivering, discomfort and respiratory depression during the operation and complications were recorded. At the end of surgery, total surgical duration was recorded and patient and surgical team were asked whether they were satisfied with the anesthesia method. Degree of satisfaction was recorded on a 5-point scale as 0 poor, 1 mediocre, 2 good, 3 very good and 4 perfect. At the end of the surgical intervention, cases were placed in supine horizontal position and taken to the recovery room. In the recovery room, patients had the verbal numerical scale (VNS) explained (0= no pain, 10= most severe pain possible) and severity of pain was recorded. Patients with VNS scores above 4 were administered pethidine (Aldolan® ampoule, Pethidine HCl 100 mg/2mL Liba/İstanbul, Gerot Pharmazeutika/Austria) IM 1 mg/kg. The time for first analgesic requirements was recorded (total analgesia duration). In the first hour in the recovery room, HR, SAP, DAP, MAP, SPO2, sensory block and motor block levels were recorded every 10 minutes. Patients with normal parameters in the recovery room were sent to the general surgery ward. SAP, DAP, MAP, sensory block levels, motor block degree and side effects were recorded on the patient monitoring form prepared for the study in the ward every 30 min from the 90th minute to 3 hours and every hour from 3rd to 6th hours and at the 8th, 10th, 16th and 24th hours. Patients were requested to report their time of first urination and time of first walking on the ward. Patients without pain during postoperative monitoring in the recovery room were requested to note the time for first analgesic requirements (total analgesia duration) and wards were visited to record this information. Patients were monitored in terms of complications like headache, back ache, urinary retention, pain in legs, weakness, urinary or anal incontinence, nausea, vomiting, hypotension, and bradycardia from after the operation until discharge. Discharge day was recorded. After discharge, they were told to inform the researchers of any problems and were telephoned and monitored for headache and temporary neurologic symptoms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Outpatients, General Surgery, Anorectal Disorder, Anesthesia, Drug Effect
    Keywords
    Saddle block, Hyperbaric levobupivacaine and bupivacaine, Outpatient anorectal surgery

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants were divided into two groups.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    This study was a double blind research.
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group L (Hyperbaric Levobupivacaine)
    Arm Type
    Experimental
    Arm Description
    7,5 mg (1.5 mL) of 0,5% hyperbaric levobupivacaine injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. In order to obtain hyperbaric levobupivacaine, 1 mL 0.75% isobaric levobupivacaine (Chirocaine® 75 mg/10mL ampoule Abbott/Turkey, Nycomed Pharma/Norway) was added to 0.24 mL 50% Dextrose (dextrose 120 mg) (Eczacıbaşı/Turkey) and 0.26 mL distilled water.
    Arm Title
    Group B (Hyperbaric Bupivacaine)
    Arm Type
    Active Comparator
    Arm Description
    7,5 mg (1.5 mL) of 0,5% hyperbaric bupivacaine (Marcaine® Spinal Heavy, 0.5%, 4 mL ampoule, AstraZeneca/England, Eczacıbaşı/Turkey, dextrose content 80 mg/mL) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds.
    Intervention Type
    Drug
    Intervention Name(s)
    Levobupivacaine (as Levobupivacaine Hydrochloride) 75 Mg/10 mL Solution for Injection Ampoule
    Other Intervention Name(s)
    1 mL 0.75% isobaric levobupivacaine (Chirocaine® 75 mg/10mL ampoule Abbott/Turkey, Nycomed Pharma/Norway) plus 0.24 mL 50% Dextrose (dextrose 120 mg) (Eczacıbaşı/Turkey) and 0.26 mL distilled water.
    Intervention Description
    7,5 mg (1.5 mL) of 0,5% hyperbaric levobupivacaine (1 mL 0.75% isobaric levobupivacaine (Chirocaine® 75 mg/10mL ampoule Abbott/Turkey, Nycomed Pharma/Norway) plus 0.24 mL 50% Dextrose (dextrose 120 mg) (Eczacıbaşı/Turkey) and 0.26 mL distilled water) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine/Dextrose
    Other Intervention Name(s)
    Marcaine® Spinal Heavy, 0.5%, 4 mL ampoule, AstraZeneca/England, Eczacıbaşı/Turkey, dextrose content 80 mg/mL.
    Intervention Description
    7,5 mg (1.5 mL) of 0,5% hyperbaric bupivacaine (dextrose content 80 mg/mL) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife.
    Primary Outcome Measure Information:
    Title
    Adequate level of anesthesia for surgery
    Description
    The time until the needle tip is not felt in all sacral dermatomes with "pin prick" test at determined time intervals after spinal anesthesia.
    Time Frame
    The first 20 minutes after administering spinal anesthesia.
    Title
    Time to obtain maximum sensory block
    Description
    The time which the highest level of dermatome is formed when the needle tip is not felt with the "pin prick" test at the specified time intervals.
    Time Frame
    Time from administering spinal anesthesia to the end of the surgery (minutes).
    Title
    The highest level of sensory block
    Description
    The highest dermatome level where the needle tip is not felt pointed with the "pin prick" test at the specified time intervals.
    Time Frame
    The maximum sensory block level reached until the end of the surgery.
    Title
    Two segment regression time of sensory block
    Description
    The time from the maximum sensory block level obtained to two segment regression
    Time Frame
    Up to 1 hour.
    Title
    The end time of sensory block
    Description
    The time from sensory block start time until sensory block is removed in all dermatomes assessed by pin prick test.
    Time Frame
    First 24 hours in postoperative period.
    Title
    The degree of maximum motor block
    Description
    With 3 points in modified Bromage score (3= lower extremities cannot be moved).
    Time Frame
    Up to 1 hour.
    Title
    The time to obtain maximum motor block degree
    Description
    The time until the maximum level of motor block with 3 points in modified Bromage score (3= lower extremities cannot be moved) after spinal anesthesia.
    Time Frame
    Up to 1 hour.
    Title
    The end time of motor block
    Description
    Time from motor block start time until the modified Bromage score returns to 0 again.
    Time Frame
    Up to 4 hours.
    Secondary Outcome Measure Information:
    Title
    Heart rate
    Description
    Heart rate as beats/minute
    Time Frame
    From entry time to operating room until postoperative first 24 hours (minutes).
    Title
    Systolic arterial pressure
    Description
    Non-invasive measurement of systolic arterial pressure (mmHg)
    Time Frame
    From entry time to operating room until postoperative first 24 hours (minutes).
    Title
    Diastolic arterial pressure
    Description
    Non-invasive measurement of diastolic arterial pressure (mmHg)
    Time Frame
    From entry time to operating room until postoperative first 24 hours (minutes).
    Title
    Mean arterial pressure
    Description
    Non-invasive measurement of mean arterial pressure (mmHg). To calculate a mean arterial pressure, double the diastolic blood pressure and add the sum to the systolic blood pressure. Then divide by 3.
    Time Frame
    From entry time to operating room until postoperative first 24 hours (minutes).
    Title
    Peripheral oxygen saturation - SpO2
    Description
    Non-invasive measurement of SpO2 (%).
    Time Frame
    From entry time to operating room until postoperative first 1 hour (minutes).
    Title
    First analgesic requirement
    Description
    The time that severity of pain measured using Verbal Numerical Scale (0= no pain, 10= most severe pain possible) above 4 points.
    Time Frame
    Up to 12 hours.
    Title
    First mobilization time
    Description
    The first time the patient can mobilize in postoperative period
    Time Frame
    Up to 6 hours.
    Title
    First voiding time
    Description
    The first time the patient can urinate in postoperative period
    Time Frame
    Up to 12 hours.
    Title
    Patient satisfaction
    Description
    Degree of satisfaction was recorded on a 5-point scale as 0 poor, 1 fair, 2 good, 3 very good and 4 perfect.
    Time Frame
    Postoperative first 24 hours.
    Title
    Surgeon satisfaction
    Description
    Degree of satisfaction was recorded on a 5-point scale as 0 poor, 1 fair, 2 good, 3 very good and 4 perfect.
    Time Frame
    Postoperative first 24 hours.
    Other Pre-specified Outcome Measures:
    Title
    Perioperative hypotension, bradycardia, nausea, vomiting and respiratory depression
    Description
    Perioperative side effects
    Time Frame
    From entry time to operating room until postoperative first 1 hour (minutes).
    Title
    Postoperative hypotension, bradycardia, nausea, vomiting, respiratory depression, headache, urinary retention, back pain
    Description
    Postoperative side effects
    Time Frame
    Postoperative first 24 hours.
    Title
    Number of patients with perioperative ephedrine administered.
    Description
    The mean arterial pressure falling more than 20% according to control values or below 60 mmHg was accepted as hypotension, and rapid fluid replacement began (50 mL/min). If there was no response within three minutes, IV bolus 5 mg ephedrine was administered.
    Time Frame
    From entry time to operating room until postoperative first 1 hour (minutes).
    Title
    Number of patients with perioperative atropine administered.
    Description
    If heart rate fell below 50 beats/min, it was evaluated as bradycardia and intravenous bolus 0.5 mg atropine was administered.
    Time Frame
    From entry time to operating room until postoperative first 1 hour (minutes).
    Title
    Number of patients discharged on operation day.
    Description
    Number of patients discharged on operation day.
    Time Frame
    The day of the surgical operation done.
    Title
    Number of patients discharged on the day after operation.
    Description
    Number of patients discharged on the day after operation.
    Time Frame
    One day after the day of the surgical operation done.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA I-II risk group with planned elective anorectal surgery Approved to participate in the study and spinal anesthesia Exclusion Criteria: Known hypersensitivity to amid-type local anesthetics Not to accept regional anesthesia administration With preoperative motor and sensory loss Not to accept participation in the study Contraindications for spinal anesthesia method
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cengiz B DEMİREL, 1
    Organizational Affiliation
    Gazi University (formerly)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparing the Effects of Levobupivacaine and Bupivacaine in Saddle Spinal Anesthesia

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