Clinical Trials Directory

Trials / Unknown

UnknownNCT03873077

Effect of LIA on Postoperative Pain Following ACL Reconstruction

Effect of Local Infiltration Analgesia on Postoperative Pain Following Anterior Cruciate Ligament Reconstruction

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Algemeen Ziekenhuis Maria Middelares · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

An anterior cruciate ligament (ACL) rupture is one of the most common sport injuries, which typically develops after a sudden knee torsion. Arthroscopic repair of the ACL is often required as a complete ACL tear can cause instability of the knee joint. During arthroscopic reconstruction the lower leg is reattached to the upper leg using part of the hamstring tendon (mm. gracilis and mm. semitendinosus). Optimal postoperative analgesia is necessary to allow a quick recovery. Intravenous analgesia during surgery is often associated with a number of side effects such as nausea, vomiting and muscle weakness and does not anesthetize the donor site of the hamstring tendon graft. Local infiltration of ropivacaine and lidocaine in the knee joint and at the donor site can be a valuable asset to control the postoperative pain. This study evaluates the effect of local infiltration analgesia (LIA) on the postoperative pain in the first month after an ACL reconstruction. Half of participants will only receive intravenous analgesia during surgery, the other half will receive intravenous analgesia and a LIA.

Detailed description

2 x 20 patients which are planned for arthroscopic ACL reconstruction are randomised: standard-group and LIA-group. All patients receive standardised multimodal intravenous analgesia. After standardised induction of anesthesia, patient positioning and administration of basic analgetics (paracetamol, diclofenac, clonidine and morfine), patients in the LIA-group receive a local infiltration in the knee of 10 mL ropivacaine and 10 mL lidocaine. Visual Analogue Scores are assessed 15 minutes after awakening from surgery and on Day 1, 2, 3, 7, 14, 21 and 28 after surgery. Postoperative analgesic consumption are registered in the first month after the surgery. The quality of recovery after anesthesia is assessed on Day 1 by the postoperative quality of recovery score (QoR-15).

Conditions

Interventions

TypeNameDescription
PROCEDURElocal infiltration analgesia10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL

Timeline

Start date
2019-03-01
Primary completion
2020-02-01
Completion
2020-03-01
First posted
2019-03-13
Last updated
2019-03-13

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03873077. Inclusion in this directory is not an endorsement.