Infiltration, Regional Anesthesia Morbidity, Rupture of Anterior Cruciate Ligament
Conditions
Brief summary
Early rehabilitation after anterior cruciate ligament reconstruction is of paramount importance and requires optimal pain control based on a multimodal concept, including injection of local anaesthetics. Regarding this latter, different options have emerged recently such as the adductor canal block, performed before the surgery by the anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of the intervention. No trial has compared these two approaches. As practice of medicine should be based on evidence, we decided to undertake this randomised controlled trial where we compared the adductor canal block with the local infiltration analgesia technique in terms of pain and functional outcomes
Detailed description
Patients scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be randomly allocated to two groups: local infiltration analgesia or adductor canal block. The local infiltration analgesia will be performed by the surgeon at the end of surgery with 20 mLs of ropivacaine 0.5%. The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance after the surgery, before awaking the patient, using the same solution (20 mLs ropivacaine 0.5%) Postoperative analgesia will include intravenous patient-controlled analgesia of morphine (settings 1 mg/ml, 2 ml/10 minutes, 40 mg/4 hours), ibuprofen (3x400 mg) and acetaminophen (4x1000 mg). A research assistant and a physiotherapist, both blinded to the group allocation, will collect pain and rehabilitation data, respectively.
Interventions
DRUGRopivacaine 0.5% 20 mLs
Injection of the local anesthetic at the end of surgery, either in the surgical sites by the surgeon, or in the adductor canal block by the anesthesiologist under ultrasound guidance.
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction
Exclusion criteria
* peripheral neuropathy * pre-existing femoral neuropathy * diabetes mellitus * alcoholism * drug addiction * cancer with chemotherapy * chronic pain state
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total morphine consumption (mg) | 24 h postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores (numeric rating scale, 0-10) at rest and on movement | 2 h postoperatively | — |
| Postoperative nausea and vomiting (yes/no) | 24 h postoperatively | — |
| Pruritus (yes/no) | 24 h postoperatively | — |
| Active flexion | 24 h postoperatively | Flexion of the knee by the patient measured in degrees |
| Total morphine consumption (mg) | 2 h postoperatively | — |
| Distance walked (meters) | 24 h postoperatively | — |
| Anterior Cruciate Ligament - Return to Sport after Injury scale | 4 months postoperatively | — |
| Anterior cruciate ligament -Return to Sport after Injury scale | 8 months postoperatively | — |
| International Knee Documentation Committee score | 4 months postoperatively | — |
| Quadriceps muscle strength (numeric scale, 1-5) | 24 h postoperatively | — |
Countries
Switzerland
Outcome results
None listed