Postoperative Pain Clinical Trial
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.
Verified date | January 2021 |
Source | Centre Hospitalier Universitaire Vaudois |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 1, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total morphine consumption (mg) | 24 hours postoperatively | ||
Secondary | Total morphine consumption (mg) | 2 hours, 48 hours and 72 hours postoperatively | ||
Secondary | 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 | |
Secondary | Rate of postoperative nausea and vomiting | Yes/No | 2hours, 24hours, 48hours and 72hours postoperatively | |
Secondary | Rate of antiemetic consumption | Yes/No | 2hours, 24hours, 48hours and 72hours postoperatively | |
Secondary | Rate of pruritus | Yes/No | 2hours, 24hours, 48hours and 72hours postoperatively | |
Secondary | Active flexion | Flexion of the knee by the patient measured in degrees | 24hours, 48hours and 72hours postoperatively | |
Secondary | Quadriceps muscle strength (numeric scale, 1-5) | 1=no contraction, 5=normal strength | 24hours, 48hours and 72hours postoperatively | |
Secondary | Distance walked (meters) | 24 hours, 48hours and 72hours postoperatively | ||
Secondary | Anterior Cruciate Ligament - Return to Sport after Injury survey | 4 and 8 postoperative months | ||
Secondary | International Knee Documentation Committee score | 4 and 8 postoperative months |
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