Clinical trial NCT03680716: Combined Saphenous Nerve and IPACK Blocks Versus Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction
Official title: Analgesic Efficacy of a Combined Saphenous Nerve Block and IPACK Block Versus Local Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Double-blinded Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Rupture
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A lot of patient have posterior knee pain after ACL reconstruction despite saphenous nerve block. Recently a new block has been described, know as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). The objective of this randomized controlled double-blinded trial is to assess whether a combined saphenous nerve block with IPACK block is more effective for the postoperative pain than a local infiltration analgesia.

Detailed description: The saphenous nerve and the iPACK will be performed after general anaesthesia induction and before the surgery under ultrasound-guidance.

The local infiltration analgesia will be performed by the surgeon during the surgery.

Eligibility criteria: Inclusion Criteria:

* Statut ASA I-III.
* Patient scheduled for anterior crutiate ligament reconstruction under general anesthesia.

Exclusion Criteria:

* Pregnancy.
* Contraindication to local anesthesia.
* Patient with chronic pain, opioid consumption or alcohol consumption.
* Patient with coagulation trouble, hepatic dysfunction or renal dysfunction.
* Patient with diabetic or femoral neuropathy.

Primary outcomes:
measure: Total morphine consumption (mg)
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Total morphine consumption (mg)
timeFrame: 2 hours, 48 hours and 72 hours postoperatively
measure: Pain scores (numeric rating scale, 0-10) at rest and on movement
timeFrame: 2hours, 24hours, 48hours and 72hours postoperatively
measure: Rate of postoperative nausea and vomiting
timeFrame: 2hours, 24hours, 48hours and 72hours postoperatively
measure: Rate of antiemetic consumption
timeFrame: 2hours, 24hours, 48hours and 72hours postoperatively
measure: Rate of pruritus
timeFrame: 2hours, 24hours, 48hours and 72hours postoperatively
measure: Active flexion
timeFrame: 24hours, 48hours and 72hours postoperatively
measure: Quadriceps muscle strength (numeric scale, 1-5)
timeFrame: 24hours, 48hours and 72hours postoperatively
measure: Distance walked (meters)
timeFrame: 24 hours, 48hours and 72hours postoperatively
measure: Anterior Cruciate Ligament - Return to Sport after Injury survey
timeFrame: 4 and 8 postoperative months
measure: International Knee Documentation Committee score
timeFrame: 4 and 8 postoperative months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
state: Vaud
Study officials:
References:
citation: Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.