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Caudal Block,Saddle Block, Anorectal Surgery

Primary Purpose

Anorectal Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
caudal block
saddle block
Sponsored by
Kocaeli Derince Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anorectal Disorder focused on measuring caudal block, saddle block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-60 years old patients
  • ASA 1-2 patients
  • Patients who will undergo anorectal surgery

Exclusion Criteria:

  • Having known hypersensitivity to amide type local anesthetics
  • Patients with contraindications to central block (caudal, saddleblock): use of anticoagulant medication, local infection in the intervention site, increased intracranial pressure, severe aortic and / or mitral valve stenosis, ischemic hypertrophic subaortic stenosis,
  • Patients who do not accept regional anesthesia

Sites / Locations

  • Derince Eğitim Ve Araştırma Hastanesi
  • Şimşek

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Caudal Block

Saddle Block

Arm Description

For the caudal block, sacral horns are palpated and sacral hiatus and epidural area will be determined at S4-S5 level through ultrasonography. The 20 G adult caudal needle will then be placed to the caudal epidural space and 25 mL bupivacaine at a concentration of 0.5% will be applied in the prone Jack-Knife position with resistance loss.

In the saddle block group hyperbaric bupivacaine at a dose of 7 mg will be given to the intrathecal space after a 25 G quincke spinal needle is inserted with ultrasonography guidance between L4-L5 vertebral disc and clear cerebrospinal fluid is seen. The patient will be placed in sitting position for 5 minutes.

Outcomes

Primary Outcome Measures

The goal is to create adequate anesthesia for the surgeon to be painless
When anesthetic agent is administered, the formation of sensory block at level lumbar 3 vertabra will be considered as an adequate level of anesthesia

Secondary Outcome Measures

The goal is to provide pain relief in the postoperative period
Pain measurement will be done with a visual analogue scale for 24 hours from the end of the operation. Visual Analog Scale (VAS) is used to convert some numerically unmeasured values into numeric values. Two extremes of a 100 mm line are to be assessed on two extremes and the patient is asked to indicate on the line where his situation is appropriate by drawing a line or placing a point or pointing. For example, for pain; no pain on one tip = 0, very severe pain = 100 on the other tip, and the patient marks his / her current state on this line. According to this chart, values of 50 mm and above are adversely affecting patient comfort. Patients with visual analog scale values above 50 mm will be intervened by making analgesic drugs.

Full Information

First Posted
April 6, 2018
Last Updated
December 26, 2018
Sponsor
Kocaeli Derince Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03498547
Brief Title
Caudal Block,Saddle Block, Anorectal Surgery
Official Title
Comparison of Caudal Block and Saddle Block on Anorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kocaeli Derince Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. Various surgical and anesthetic techniques have been used to increase the level of analgesia in perioperative period and decrease the length of stay in the hospital. In this study, investigators investigate the effects of routinely applied anesthesia techniques during anorectal surgery, caudal block and saddle block, on patients' perioperative hemodynamic values, sensory and motor block levels, and postoperative pain scores.
Detailed Description
Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. Various surgical and anesthetic techniques have been used to increase the level of patients perioperative analgesia and decrease the length of stay in the hospital. Spinal Saddle block anesthesia applications are performed while the patient is in the sitting position. Local anesthetic is given into the intrathecal space and it is aimed to localize the applied agent around the hip and anorectal region with the effect of gravity. Thus, sufficient level of anesthesia required during perianal region surgery and stable patient hemodynamics is provided. Caudal block is widely used in both adults and pediatric patients for intraoperative anesthesia and chronic pain management. Sacral hyperattenuation is performed to reach the epidural space, a local anesthetic agent is given to the epidural space, it is accepted as an easy and safe method and therefore it is frequently used in anorectal surgeons. In this study, investigators investigate the effects of routinely applied anesthesia techniques during anorectal surgery, caudal block and saddle block, on patients' perioperative hemodynamic values, sensory and motor block levels, and postoperative pain scores. Elective anorectal surgery planned 100 patients between the 18-60 ages. The risk of anesthesia in patients will be determined by ASA (American Society Of anesthesiologists), ASA1 or ASA 2 risk group will be included after informed consents are approved. Patient electrocardiogram (ECG), peripheral oxygen saturation (SpO2), non-invasive blood pressure monitor will be performed in the operation room. Baseline hemodynamic-vital parameters of the patients will be recorded. Patients undergoing caudal and saddle blocks, will be compared as two randomized groups. In the saddle block group hyperbaric bupivacaine at a dose of 7 mg will be given to the intrathecal space after a 25 G quincke spinal needle is inserted with ultrasonography guidance between L4-L5 vertebral disc and clear cerebrospinal fluid is seen. The patient will be placed in sitting position for 5 minutes. For the caudal block, sacral horns are palpated and sacral hiatus and epidural area will be determined at S4-S5 level through ultrasonography. The 20 G adult caudal needle will then be placed to the caudal epidural space and 25 mL bupivacaine at a concentration of 0.5% will be applied in the prone Jack-Knife position with resistance loss. Sensory and motor block level, heart rate (HR), systolic arterial pressure (SAB), diastolic arterial pressure (DAB), mean arterial pressure (OAB) and SpO2 levels will be measured every 5 minutes until the end of the operation. Sensory block level will be evaluated with "pinprick" test. Motor block level will be evaluated by using Modified Bromage Scale (0 = no paralysis, thigh, leg and foot can be removed, 1 = unable to move the thigh, move the knee,2 = cannot move the knee, can move the ankle, 3 = cannot move the lower extremities at all) Once sensory block level is reached to the L3 level the surgical procedure will begin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorectal Disorder
Keywords
caudal block, saddle block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caudal Block
Arm Type
Active Comparator
Arm Description
For the caudal block, sacral horns are palpated and sacral hiatus and epidural area will be determined at S4-S5 level through ultrasonography. The 20 G adult caudal needle will then be placed to the caudal epidural space and 25 mL bupivacaine at a concentration of 0.5% will be applied in the prone Jack-Knife position with resistance loss.
Arm Title
Saddle Block
Arm Type
Active Comparator
Arm Description
In the saddle block group hyperbaric bupivacaine at a dose of 7 mg will be given to the intrathecal space after a 25 G quincke spinal needle is inserted with ultrasonography guidance between L4-L5 vertebral disc and clear cerebrospinal fluid is seen. The patient will be placed in sitting position for 5 minutes.
Intervention Type
Procedure
Intervention Name(s)
caudal block
Intervention Description
For the caudal block, sacral horns are palpated and sacral hiatus and epidural area will be determined at S4-S5 level through ulştrasonography. The 20 G adult caudal needle will then be placed to the caudal epidural space and 25 mL bupivacaine at a concentration of 0.5% will be applied in the prone Jack-Knife position with resistance loss.
Intervention Type
Procedure
Intervention Name(s)
saddle block
Intervention Description
In the saddle block group hyperbaric bupivacaine at a dose of 7 mg will be given to the intrathecal space after a 25 G quincke spinal needle is inserted with ultrasonographyguidance between L4-L5 vertebral disc and clear cerebrospinal fluid is seen. The patient will be placed in sitting position for 5 minutes.
Primary Outcome Measure Information:
Title
The goal is to create adequate anesthesia for the surgeon to be painless
Description
When anesthetic agent is administered, the formation of sensory block at level lumbar 3 vertabra will be considered as an adequate level of anesthesia
Time Frame
Sufficient anesthesia is expected within 30 minutes after the anesthetic agent is applied
Secondary Outcome Measure Information:
Title
The goal is to provide pain relief in the postoperative period
Description
Pain measurement will be done with a visual analogue scale for 24 hours from the end of the operation. Visual Analog Scale (VAS) is used to convert some numerically unmeasured values into numeric values. Two extremes of a 100 mm line are to be assessed on two extremes and the patient is asked to indicate on the line where his situation is appropriate by drawing a line or placing a point or pointing. For example, for pain; no pain on one tip = 0, very severe pain = 100 on the other tip, and the patient marks his / her current state on this line. According to this chart, values of 50 mm and above are adversely affecting patient comfort. Patients with visual analog scale values above 50 mm will be intervened by making analgesic drugs.
Time Frame
Postoperative follow-up for analgesia is 24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-60 years old patients ASA 1-2 patients Patients who will undergo anorectal surgery Exclusion Criteria: Having known hypersensitivity to amide type local anesthetics Patients with contraindications to central block (caudal, saddleblock): use of anticoagulant medication, local infection in the intervention site, increased intracranial pressure, severe aortic and / or mitral valve stenosis, ischemic hypertrophic subaortic stenosis, Patients who do not accept regional anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tahsin şimşek, MD
Organizational Affiliation
KOCAELİ DERİNCE EĞİTİM VE ARAŞTIRMA HASTANESİ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
kemal tolga saracoğlu, MD
Organizational Affiliation
KOCAELİ DERİNCE EĞİTİM VE ARAŞTIRMA HASTANESİ
Official's Role
Study Director
Facility Information:
Facility Name
Derince Eğitim Ve Araştırma Hastanesi
City
Kocaeli
State/Province
Derince
ZIP/Postal Code
41000
Country
Turkey
Facility Name
Şimşek
City
Kocaeli
State/Province
Derince
ZIP/Postal Code
41000
Country
Turkey

12. IPD Sharing Statement

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Caudal Block,Saddle Block, Anorectal Surgery

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