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
About this trial
This is an interventional supportive care trial for Pain, Postoperative
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
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
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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