- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05136352
Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery (Liga-PACK)
Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery, the LIGA-PACK Study
Study Overview
Status
Intervention / Treatment
Detailed Description
The ideal loco-regional anesthesia for anterior cruciate ligament reconstruction ensuring a satisfying analgesia without compromising an early rehabilitation is still undetermined.
Femoral nerve block has been incriminated in a delayed postoperative mobilization whereas the adductor canal block gives an equivalent analgesia for a better preservation of the quadricipital muscular strength.
The iPACK block (infiltration between the popliteal artery and the capsule of the posterior knee) is a recently described technique. Few studies have assessed the iPACK block in ACL reconstruction, and none were randomized.
This randomized single blind clinical trial compares two groups of 45 patients who undergo ACL reconstruction surgery under general anaesthetic : one receives an iPACK block associated with an adductor canal block, and the other only has an adductor canal block.
Pain scores and opioid consumption are collected after surgery in the recovery room, then by telephone interview at 24 and 48 hours post-surgery. Functional rehabilitation is evaluated by scales (KOOS, LYSHOLM and iKDC) at 3, 6 and 9 months after surgery. Adverse effects, due to anesthesia or opioids, are collected from 30 min after loco-regional anesthesia until the second phone call at 48h post-surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Toulouse, France
- University Hospital of Toulouse
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- ACL repair surgery under general anesthesia
- Person affiliated or beneficiary of a social security plan
- Free, informed and written consent
Exclusion Criteria:
- Age < 18 years
- Contraindication to ALR (allergy to local anesthetics, local infection of the puncture site, coagulopathy)
- Pre-existing opiate dependence
- Contraindication to non-steroidal anti-inflammatory drugs
- Pregnant or potentially pregnant women
- Patients under the protection of adults (guardianship, curatorship or safeguard of justice)
- Patients whose cognitive state does not allow evaluation by the scales used
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: adductor canal block
loco-regional analgesia with adductor canal block (ACB) method (for anterior cruciate ligament reconstruction )
|
loco-regional anesthesia using adductor canal block
Other Names:
|
|
Experimental: iPACK block
loco-regional analgesia with iPACK block (infiltration between the popliteal artery and the capsule of the posterior knee) ((for anterior cruciate ligament reconstruction )
|
loco-regional anesthesia using infiltration between the popliteal artery and the capsule of the posterior knee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative opioid consumption at 48 hours after surgery
Time Frame: Hours 48
|
Cumulative opioid consumption in the first 48 hours after anterior cruciate ligament repair surgery
|
Hours 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative opioid consumption at 2 hours after surgery
Time Frame: Hours 2
|
Cumulative opioid consumption in the recovery room after anterior cruciate ligament repair surgery
|
Hours 2
|
|
Cumulative opioid consumption at 24 hours after surgery
Time Frame: Hours 24
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Cumulative opioid consumption in the first 24 hours after anterior cruciate ligament repair surgery
|
Hours 24
|
|
Cumulative opioid consumption at 3 months
Time Frame: month 3
|
total opioid consumption at 3 months after anterior cruciate ligament repair surgery
|
month 3
|
|
Maximum pain score in the recovery room
Time Frame: hours 2
|
Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score)
|
hours 2
|
|
Maximum pain score at 24 hours after surgery
Time Frame: hours 24
|
Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score)
|
hours 24
|
|
Maximum pain score at 48 hours after surgery
Time Frame: hours 48
|
Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score)
|
hours 48
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fabrice FERRE, MD, University Hospital, Toulouse
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RC31/21/0167
- 2021-A01226-35 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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