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Ketamine and Dexmedetomidine Comparative Study

Primary Purpose

Post Operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
combined ultra-sound guided femoral and sciatic nerve block.
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post Operative Pain

Eligibility Criteria

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

Inclusion Criteria: 50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study. - Exclusion Criteria: Patient refusal. Patient with significant neurological, psychiatric or neuromuscular disease. Alcoholism. Drug abuse. Pregnancy or lactating women. Suspected Coagulopathy. Morbid obesity. Known allergy to study medications. Septicaemia and local infection at the block site.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ketamine group (group K)

    Dexmedetomidine group (group D)

    Arm Description

    Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine.

    Dexmedetomidine group (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine.

    Outcomes

    Primary Outcome Measures

    the onset of the femoral nerve block
    The time interval between the deposition of the local anesthetic and the loss of pinprick sensation at the site of surgery.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 9, 2022
    Last Updated
    September 8, 2023
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06032624
    Brief Title
    Ketamine and Dexmedetomidine Comparative Study
    Official Title
    Comparative Study Between Ketamine and Dexmedetomidine as Additives to Local Anesthetic in Ultrasound-guided Combined Sciatic and Femoral Nerve Block
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    July 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    In this study, the investigators will compare the effect of adding ketamine and dexmedetomidine to bupivacaine in US-guided combined sciatic and femoral nerve blocks as regards the onset and duration of the block, postoperative visual analogue scale, and analgesic consumption.50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study.
    Detailed Description
    The patients will be randomly classified into two groups: Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine, Dexmedetomidine group (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine. Femoral nerve block: The femoral area will be sterilized using povidone-iodine and alcohol and then drapes will be put on the patient's thigh, with the operator on the right-hand side for blocks on both sides and vice versa for a left-handed operator. The ultrasound machine will be placed on the opposite side so that the operator's line of sight, the needle, and the screen are in a straight line. The femoral area will be scanned behind the midpoint of the inguinal ligament and the depth of the image will be set at 3-5 cm and a linear high frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve., medial to the lateral sliding movements of the transducer-aided visualization of the pulsatile femoral artery. Structures that will be visualized: fascia iliac, femoral artery, immediately below, and lateral is the femoral nerve in a wedge-shaped space. The femoral nerve typically is hyperechoic and lies in a sulcus in the iliopsoas inferiorly. In-line insertion of the needle to reach below fascia iliaca and then a volume of 15 ml of bupivacaine will be injected to perform the block. Sciatic nerve block: The patient will be positioned with the side for the block uppermost, flexed partially at the hip and knee joints. The iliac area will be sterilized using povidone-iodine and alcohol, and then drapes will be put on the patient's thigh, with the operator on the right-hand side for blocks on both sides and vice versa for a lefthanded operator. The ultrasound machine will be placed on the opposite side so that the operator's line of sight, the needle, and the screen is in a straight line. A curvilinear low-frequency (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences; the gluteus maximus muscle is as the most superficial muscular layer bridging the two osseous structures; sciatic nerve lies deep into the gluteus maximus muscle and superficial to the quadratus femoris muscle as an oval or roughly triangular hyperechoic structure. A volume of 25 ml of bupivacaine will be injected to perform the block. The onset and duration of sensory loss and motor blockade will be studied. The loss of pinprick sensation will be checked every 5 minutes till the onset of loss of sensation and then every 2 hours till the regain of sensation. The motor blockade will be assessed every 5 minutes till the loss of movements and then every 2 hours till the regain of movements. The onset of action: Sensory and motor blockade Sensory block: The time interval between full deposition of local anesthetic solution till loss of pinprick sensation at the site of surgery. Motor block: The time interval between administering the local anesthetic solution to the loss of movements. Duration of blockade: Sensory block: Time interval between loss of pinprick sensation to the appearance of pinprick sensation. Motor block: Time interval between loss of movements to the appearance of the movements. The basal heart rate (HR); noninvasive arterial systolic blood pressure (SBP) and diastolic blood pressure (DBP); and peripheral oxygen saturation (SpO2) will be recorded. An 18-gauge (G) i.v. the cannula will be inserted in the non-operated arm and lactated Ringer's solution will be started at 5 ml/kg/h. HR, SBP, and DBP will also be recorded at 0, 5, 10, 15, 30, 45-, 60-, 90-, and 120-min. Adverse effects will be considered as hypotension (i.e., 20% decrease relative to baseline), bradycardia (HR <50 beats/min), nausea, vomiting, and hypoxemia (SpO2 <90%). Any need for additional medication will be noted intraoperatively. Blood loss will be calculated by the gravimetric method and will be replaced if more than the allowable blood loss. Pain will be assessed using a visual analog scale (VRS) (O=no pain 1=mild pain 2=moderate pain 3=severe pain 4=unbearable pain).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Operative Pain

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketamine group (group K)
    Arm Type
    Active Comparator
    Arm Description
    Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine.
    Arm Title
    Dexmedetomidine group (group D)
    Arm Type
    Active Comparator
    Arm Description
    Dexmedetomidine group (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine.
    Intervention Type
    Procedure
    Intervention Name(s)
    combined ultra-sound guided femoral and sciatic nerve block.
    Intervention Description
    Femoral nerve block, The femoral area will be scanned behind the midpoint of the inguinal ligament and the depth of the image will be set at 3-5 cm, and a linear high frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve., the volume of 15 ml of bupivacaine will be injected to perform the block. Sciatic nerve block, A curvilinear low-frequency (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences,A volume of 25 ml of bupivacaine will be injected to perform the block.
    Primary Outcome Measure Information:
    Title
    the onset of the femoral nerve block
    Description
    The time interval between the deposition of the local anesthetic and the loss of pinprick sensation at the site of surgery.
    Time Frame
    from the deposition of the local anesthetic till the loss of pinprick sensation

    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: 50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study. - Exclusion Criteria: Patient refusal. Patient with significant neurological, psychiatric or neuromuscular disease. Alcoholism. Drug abuse. Pregnancy or lactating women. Suspected Coagulopathy. Morbid obesity. Known allergy to study medications. Septicaemia and local infection at the block site.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed Mahmoud, MD
    Phone
    00201091328413
    Email
    mohamedmahmoud@med.sohag.edu.eg

    12. IPD Sharing Statement

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    Ketamine and Dexmedetomidine Comparative Study

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