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

Not Applicable

Completed

• Conditions: Postoperative Pain; Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture
• Interventions: Drug: Ropivacaine injection

• Registration Number: NCT03680716
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-21
• Study Start: 2018-11-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPACK block	Ropivacaine injection	Saphenous nerve block and IPACK block by anesthetist under ultrasound guidance.
Local infiltration analgesia	Ropivacaine injection	Periarticular infiltration by surgeon

Primary Outcome Measures

Name	Time	Method
Total morphine consumption (mg)	24 hours postoperatively

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland