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IPACK Block Versus Adductor Canal Block in High Tibeal Osteotomy

Primary Purpose

Pain, Postoperative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Infiltration of local anaesthetic between popliteal artery and posterior knee capsule
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 40 - 60 years.
  2. American Society of Anesthiologist class ( ASA) I - III
  3. BMI 18-35 kg/m2
  4. Scheduled for primary unilateral open wedge high tibial osteotomy

Exclusion Criteria:

  1. Known allergy to local anesthetics
  2. Contraindication to local anesthetics injection e.g. infection at the site of injection
  3. Contraindication to spinal anesthesia e.g. coagulopathy.
  4. Patients with pre-existing motor or sensory deficits in lower extremities.
  5. Insulin or noninsulin dependent diabetes mellitus.
  6. systemic corticosteroid use within 30-days of surgery
  7. difficulties in comprehending visual analog scale (VAS) pain scores
  8. history of arrhythmia or seizures
  9. severe renal insufficiency

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group 1 who will receive IPACK block

    Group 2 who will receive adductor canal block

    Arm Description

    This group of patients will receive IPACK block immediately before spinal anaesthesia then follow up for 24 hrs to register first pain sensation and analgesic requirements

    This group of patients will receive adductor canal block immediately before spinal anaesthesia then follow up for 24 hrs to register first pain sensation and analgesic requirements

    Outcomes

    Primary Outcome Measures

    the time of first pain sensation requiring analgesia
    If intervention which is adductor canal block or lPACK block is effective in postoperative pain control that can decrease the lV analgesic agents

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2022
    Last Updated
    March 6, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05271188
    Brief Title
    IPACK Block Versus Adductor Canal Block in High Tibeal Osteotomy
    Official Title
    Infiltration of Local Anesthetic in the Interspace Between the Popliteal Artery and Capsule of the Posterior Knee "IPACK Block" Versus Adductor Canal Block "ACB" for Pain Relief After Open Wedge High Tibial Osteotomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 15, 2022 (Anticipated)
    Primary Completion Date
    February 2023 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    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
    A comparison between IPACK block and adductor canal block in post operative pain management
    Detailed Description
    Two groups of patients between 40 and 60 yrs who are undergoing open wedge high tibeal osteotomy Group 1 will receive IPACK block with 15 ml Bupivacaine, immediately before spinal anaesthesia . Group 2 will receive adductor canal block ,also with 15 ml Bupivacaine. before spinal anaesthesia. register the time of first pain sensation and firs IV analgesic dose required in each group

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups of people who are undergoing open wedge high tibeal osteotomy aged between 40 and 60 yrs old not diabetic and neurologically free
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 who will receive IPACK block
    Arm Type
    Active Comparator
    Arm Description
    This group of patients will receive IPACK block immediately before spinal anaesthesia then follow up for 24 hrs to register first pain sensation and analgesic requirements
    Arm Title
    Group 2 who will receive adductor canal block
    Arm Type
    Active Comparator
    Arm Description
    This group of patients will receive adductor canal block immediately before spinal anaesthesia then follow up for 24 hrs to register first pain sensation and analgesic requirements
    Intervention Type
    Procedure
    Intervention Name(s)
    Infiltration of local anaesthetic between popliteal artery and posterior knee capsule
    Other Intervention Name(s)
    Adductor canal block
    Intervention Description
    Adductor canal block (ACB) is a popular peripheral nerve block that has been shown to decrease pain significantly and thereby opioid consumption with minimal effect on quadriceps function [8]. Though ACB provides analgesia to the peripatellar and intra-articular aspect of knee joint, it does not relieve posterior knee pain which is moderate to severe in intensity [9, 10]. The recent technique of an ultrasound (US)-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown to provide significant posterior knee analgesia without affecting the common peroneal nerve (CPN) [11]. We postulated that IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB
    Primary Outcome Measure Information:
    Title
    the time of first pain sensation requiring analgesia
    Description
    If intervention which is adductor canal block or lPACK block is effective in postoperative pain control that can decrease the lV analgesic agents
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 40 - 60 years. American Society of Anesthiologist class ( ASA) I - III BMI 18-35 kg/m2 Scheduled for primary unilateral open wedge high tibial osteotomy Exclusion Criteria: Known allergy to local anesthetics Contraindication to local anesthetics injection e.g. infection at the site of injection Contraindication to spinal anesthesia e.g. coagulopathy. Patients with pre-existing motor or sensory deficits in lower extremities. Insulin or noninsulin dependent diabetes mellitus. systemic corticosteroid use within 30-days of surgery difficulties in comprehending visual analog scale (VAS) pain scores history of arrhythmia or seizures severe renal insufficiency
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Salwa Hussein
    Phone
    01159460234
    Email
    salwa94hussien@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abd elraheem Mahmoud
    Phone
    01000032655
    Email
    arawamyyy@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Salwa Hussein, Lecturer
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    IPACK Block Versus Adductor Canal Block in High Tibeal Osteotomy

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