Anterior Cruciate Ligament (ACL) Tear, Arthroscopic Anterior Cruciate Ligament Reconstruction
Conditions
Keywords
periarticular injection, morphine consumption, pain control
Brief summary
In this prospective, assessor-blinded, single-surgeon clinical trial, the goal was to validate the efficacy of PAI in aACLR surgery with a reduced opioid dose, while achieving similar pain relief with few adverse events. 300 patients who had undergone aACLR were randomly allocated to receive either a PAI or nPAI group. The primary outcome parameters were visual analogue scale (VAS) scores and cumulative morphine dose, through time. Secondary outcome parameters included drug-related adverse events.
Interventions
COMBINATION_PRODUCTPeriarticular injection
A 50ml periarticular injection was introduced intraoperatively before the time of closing. The injection contained 150mg bupivacaine (3mg/mL), 60mg ketorolac(1.2mg/mL) and 1mg morphine. Before wound closure, periarticular cocktail was injected around the knee joint including the adductor canal from the hamstring harvest side in PAI group. All patients had oral paracetamol 500mg, 4 times/day and diclofenac 75mg, 1 times/day after surgery.
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\) Patients 18 years or older who had undergone a-ACLR with or without meniscus procedure for anterolateral instability of the knee; 2) agree to participate in this study and to be randomly allocated to either or peri-articular injection protocol and have signed an informed consent.
Exclusion criteria
* 1\) patients with other concomitant injuries such as other ligamentous injury or fracture; 2) Allergy to any of the medication used in either protocol; 3) patient with history of the chronic pain 4) preoperative chronic opioid-dependent patients (exceeding 50 mg oral morphine equivalence per day at time of recruitment); 5) refuse to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS scores | at different time points (postoperative 4,8,24-hour, before discharge) after surgery |
Secondary
| Measure | Time frame |
|---|---|
| cumulative morphine consumption (mg) | at post-operative 4, 8, 24-hour and before discharge |
Other
| Measure | Time frame |
|---|---|
| drug related adverse events | within postoperative 2 weeks |
| overall satisfaction scale (0-100 points) | at postoperative 2 weeks |
Countries
Taiwan
Outcome results
None listed