Effect of LIA on Postoperative Pain Following ACL Reconstruction

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Anterior Cruciate Ligament Rupture, Pain, Postoperative

Intervention / Treatment
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* Procedure: local infiltration analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective arthroscopic anterior cruciate ligament reconstruction adult Exclusion Criteria: unwilling or unable to grant written informed consent revisions contra-indication for ropivacaine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A receives standard treatment (intravenous analgesia). Group B received intravenous analgesia and a LIA.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: intravenous analgesia<br>Patient receives intravenous analgesia: paracetamol 30 mg/kg, diclofenac 75 mg, clonidine 1 µg/kg and morfine 0,05 mg/kg | |
| Other: intravenous analgesia + LIA<br>Patient receives intravenous analgesia and a local infiltration analgesia in the knee | Procedure: local infiltration analgesia<br>* 10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale for pain | Pain intensity using the VAS (where 0 = no pain and 100 = pain as bad as can be) 15 minutes after awakening and on Day 1, 2, 3, 7, 14, 21 and 28 after surgery. | From moment of surgery until one month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesia consumption | Dosing and frequency of analgesia consumption | From moment of surgery until one month after surgery | 
| General patient comfort | Quality of recovery score (QoR-15) on the first day after surgery | From moment of surgery until one day after surgery | 
| Incidence of nausea and vomiting | Incidence of postoperative nausea and vomiting | From moment of surgery until hospital discharge (one day after surgery) | 
| PONV treatment | Number of pharmacological treatments for postoperative nausea and vomiting (PONV) | From moment of surgery until hospital discharge (one day after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local infiltration analgesia, postoperative analgesia