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Effect of LIA on Postoperative Pain Following ACL Reconstruction

A

Algemeen Ziekenhuis Maria Middelares

Status

Unknown

Conditions

Pain, Postoperative
Anterior Cruciate Ligament Rupture

Treatments

Procedure: local infiltration analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT03873077
MMS.2019.001

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • elective arthroscopic anterior cruciate ligament reconstruction
  • adult

Exclusion criteria

  • unwilling or unable to grant written informed consent
  • revisions
  • contra-indication for ropivacaine

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

intravenous analgesia
No Intervention group
Description:
Patient receives intravenous analgesia: paracetamol 30 mg/kg, diclofenac 75 mg, clonidine 1 µg/kg and morfine 0,05 mg/kg
intravenous analgesia + LIA
Other group
Description:
Patient receives intravenous analgesia and a local infiltration analgesia in the knee
Treatment:
Procedure: local infiltration analgesia

Trial contacts and locations

1

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Central trial contact

Alain F Kalmar, MD, PhD, MSc; Pieter Byn, MD, Msc

Data sourced from clinicaltrials.gov

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