Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT02524652

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-03-31

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.

Conditions

Rupture of Anterior Cruciate Ligament; Infiltration; Regional Anesthesia Morbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Local infiltration analgesia

Infiltration of the knee by the surgeon with local anaesthetics under general anaesthesia.

Group Type: EXPERIMENTAL

Ropivacaine 0.5% 20 mLs

Intervention Type: DRUG

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.

Adductor canal block

Injection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist after the surgery, before awaking the patient.

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.5% 20 mLs

Intervention Type: DRUG

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.

Interventions

Ropivacaine 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.

Intervention Type: DRUG

Other Intervention Names

Naropine, Naropin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Eric Albrecht

Program Director, Regional Anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Albrecht, PD Dr

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.

Reference Type: DERIVED

PMID: 31130273 (View on PubMed)

Other Identifiers

CER 193-15

Identifier Type: -

Identifier Source: org_study_id