Combined Saphenous Nerve and IPACK Blocks Versus Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction

Study Overview
=================
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.

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.

Conditions
-----------------
Postoperative Pain, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture

Intervention / Treatment
-----------------
* Drug: Ropivacaine injection
* Drug: Ropivacaine injection


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPACK block<br>Saphenous nerve block and IPACK block by anesthetist under ultrasound guidance. | Drug: Ropivacaine injection<br>* Saphenous nerve block with 20ml of ropivacaine 0.5% and IPACK block with 30ml of ropivacaine 0.2% (total dose of 160 mg).<br>|
| Active Comparator: Local infiltration analgesia<br>Periarticular infiltration by surgeon | Drug: Ropivacaine injection<br>* Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption (mg) |  | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption (mg) |  | 2 hours, 48 hours and 72 hours postoperatively | 
| Pain scores (numeric rating scale, 0-10) at rest and on movement | 0= no pain, 10=the worst pain imaginable | 2hours, 24hours, 48hours and 72hours postoperatively | 
| Rate of postoperative nausea and vomiting | Yes/No | 2hours, 24hours, 48hours and 72hours postoperatively | 
| Rate of antiemetic consumption | Yes/No | 2hours, 24hours, 48hours and 72hours postoperatively | 
| Rate of pruritus | Yes/No | 2hours, 24hours, 48hours and 72hours postoperatively | 
| Active flexion | Flexion of the knee by the patient measured in degrees | 24hours, 48hours and 72hours postoperatively | 
| Quadriceps muscle strength (numeric scale, 1-5) | 1=no contraction, 5=normal strength | 24hours, 48hours and 72hours postoperatively | 
| Distance walked (meters) |  | 24 hours, 48hours and 72hours postoperatively | 
| Anterior Cruciate Ligament - Return to Sport after Injury survey |  | 4 and 8 postoperative months | 
| International Knee Documentation Committee score |  | 4 and 8 postoperative months |