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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03680716
Other study ID # CER 2018-01163
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date October 1, 2020

Study information

Verified date January 2021
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injuries
  • Anterior Cruciate Ligament Injury
  • Anterior Cruciate Ligament Rupture
  • Postoperative Pain
  • Rupture

Intervention

Drug:
Ropivacaine injection
Saphenous nerve block with 20ml of ropivacaine 0.5% and IPACK block with 30ml of ropivacaine 0.2% (total dose of 160 mg).
Ropivacaine injection
Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).

Locations

Country Name City State
Switzerland Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

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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