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Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery

Primary Purpose

Perianal Fistula, Hemorrhoids

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ketamine
bupivacaine
Sponsored by
Esam Eldin Mohamed Abdalla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Perianal Fistula focused on measuring Perianal fistula, Hemorrhoids

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects will be included in the study only if they meet all of the following criteria:
  • Patients scheduled for perianal surgeries.
  • Age 18-55 years.
  • ASA physical status I-II.

Exclusion Criteria:

  • Subjects will be excluded from the study for any of the following reasons:
  • Patient refusal
  • Any contraindication of regional anaesthesia
  • Failed Technique

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    The ketamine group

    The control group

    Arm Description

    The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total volume is 2 ml will injected

    group will receive only intrathecal bupivacaine (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml.

    Outcomes

    Primary Outcome Measures

    - Duration of saddle block
    (time from intrathecal injection to the time of first complain of pain, first request for analgesia, or a reported NRS >4)

    Secondary Outcome Measures

    Evaluation of the need of supplemental analgesia
    time of 1st dose

    Full Information

    First Posted
    May 29, 2017
    Last Updated
    January 13, 2018
    Sponsor
    Esam Eldin Mohamed Abdalla
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03264430
    Brief Title
    Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
    Official Title
    Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    October 31, 2018 (Anticipated)
    Study Completion Date
    December 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Esam Eldin Mohamed Abdalla

    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
    No

    5. Study Description

    Brief Summary
    Evaluation of the anesthetic quality and analgesic efficacy of adding ketamine to intrathecal bupivavaine in selective saddle block for perianal surgery.
    Detailed Description
    This study will be carried out in Assiut University Hospitals, General Surgery Operative room and Post Anaesthesia Care Unit (PACU). This study will include 60 adult participants (ASA I&II) scheduled for minor perianal surgery (perianal fistula, haemorrhoids or both). After approval of ethics committee and written informed consent will be obtained from the participants. Investigators will exclude participants with classic contraindications to spinal block, pre-existing systemic disease (such as cardiovascular, respiratory or renal diseases), coagulopathy and participants taking any medications that could influence the haemodynamic response. The selected participants will be divide into two groups (30 participants for each group), ketamine group and placebo (control) group. The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total volume is 2 ml will injected. The control group will receive only intrathecal bupivacaine (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml. Anaesthetic technique participants will receive oral medication 60 minutes preoperatively with 0.5 mg/kg of midazolam. After arrival at the OR, an intravenous (IV) 18-20G catheter was placed and infusion of 20 ml/kg NaCl 0.9% will start. Standard monitoring electrocardiogram (ECG), heart rate (HR), oxygen saturation (SpO2), and non-invasive blood pressure (BP) will be started. Dural puncture was made in the sitting position with a 25 gauge spinal needle using a median approach. After aspiration, the dose of anaesthetic as indicated in the envelope was injected over two minutes. The time of Dural puncture was used as the Primary starting point of assessment. The medications injection will be over 10 s with no barbotage and the needle orifice cephaled. After intrathecal injection, participants will kept sitting for 10 minutes, after that the patient will lie in the lithotomy position and received 100% O2 (4 L/min) with face mask. Ten minutes after the Dural puncture, participants will asked to lie down and the level of sensory block will tested with an alcohol swab. Motor block was tested by modified Bromage scale (0 = no motor block, 1 = able to flex ankle and bend knees, 2 = able to flex ankle, and 3 = full motor block) [21], and surgery in the supine position will allow to started. In case of failed block, general anaesthesia will be induced. Non-invasive BP taken every 5 minutes and HR were assessed in the OR. Reduction of mean BP (MAP) and HR >20% from baseline was judged clinically significant. A decrease in systolic BP below 90 mmHg will be treated with 5 mg of IV ephedrine, HR<45 beats per minute (bpm) will be treated with 0.5 mg of IV atropine. Patient assessment: Demographics (age, gender, type of surgery); duration of anesthesia (from the moment of dural puncture until patient left the OR) and surgery in minutes. Rate of success (failed block, number of attempts made, ease of performance scale 1-3, where 3 = easy to perform, 2 =moderate, 1 = difficult, multiple attempts needed); level of sensory (dermatomes) and motor (Bromage scale) block10 minutes after dural puncture, at the end of surgery, and in the ward every 30 minutes until resolution of the block and afterwards at 6, 9, 12, 18 and 24 hours postoperatively; MAP and HR every 5 minutes in the OR, then every 4 hours for postoperative 24 hours; Complications during performance of anesthesia: paresthesias, toxic reactions, Level of postoperative pain on a written VAS scale (0-10 mm). Time of 1st analgesic request, and number of requests for each patient will be recorded in the 1st 24 hours. Consumption of rescue analgesia; if VAS is ≥ 5 in the form of 30 mg intramuscular (IM) repeated twice as patient satisfaction and 0.1mg of morphine for up stocking of pain Postoperative complications: - Urinary retention (0-2 scale, where 0 = normal urination, 1 = difficult spontaneous urination, and 2 = unable to urinate, catheterization needed. Postoperative nausea and vomiting (PONV; 0-3 scale, where 0 = no nausea, 1 = slight nausea, 2 = nausea and single vomiting, and 3 = multiple vomiting) [15], Postdural puncture headache (PDPH) at day 1 postoperatively and 10 days later by phone call at home, Transient neurologic symptoms (TNS), backache, itching, allergic reactions, time of postoperative recovery, time to urinate, duration of sensory and motor block, and time to stand and walk unsupported Statistical analysis The data will be recorded on and analyzed using SPSS-12. The results will be presented as Mean ±SD or percent of patients. For proportions, Pearson test or Fisher's test will be used. Student's t-test being used for quantitative variables. A p-value of <0.05 will be considered to show statistical significance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perianal Fistula, Hemorrhoids
    Keywords
    Perianal fistula, Hemorrhoids

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    The ketamine group
    Arm Type
    Active Comparator
    Arm Description
    The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total volume is 2 ml will injected
    Arm Title
    The control group
    Arm Type
    Placebo Comparator
    Arm Description
    group will receive only intrathecal bupivacaine (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    ketalar
    Intervention Description
    an antagonist of the NMDA receptor
    Intervention Type
    Drug
    Intervention Name(s)
    bupivacaine
    Other Intervention Name(s)
    marcaine 0.5 %
    Intervention Description
    local anaesthetic
    Primary Outcome Measure Information:
    Title
    - Duration of saddle block
    Description
    (time from intrathecal injection to the time of first complain of pain, first request for analgesia, or a reported NRS >4)
    Time Frame
    24 hours post-operative
    Secondary Outcome Measure Information:
    Title
    Evaluation of the need of supplemental analgesia
    Description
    time of 1st dose
    Time Frame
    24 hours post-operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects will be included in the study only if they meet all of the following criteria: Patients scheduled for perianal surgeries. Age 18-55 years. ASA physical status I-II. Exclusion Criteria: Subjects will be excluded from the study for any of the following reasons: Patient refusal Any contraindication of regional anaesthesia Failed Technique

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery

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