NCT02524652

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

2.5 years

First QC Date

August 6, 2015

Last Update Submit

May 4, 2018

Conditions

Rupture of Anterior Cruciate LigamentInfiltrationRegional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption (mg)

    24 h postoperatively

Secondary Outcomes (29)

  • Total morphine consumption (mg)

    2 h postoperatively

  • Total morphine consumption (mg)

    48 h postoperatively

  • Total morphine consumption (mg)

    72 h postoperatively

  • Pain scores (numeric rating scale, 0-10) at rest and on movement

    2 h postoperatively

  • Pain scores (numeric rating scale, 0-10) at rest and on movement

    12 h postoperatively

  • +24 more secondary outcomes

Study Arms (2)

Local infiltration analgesia

EXPERIMENTAL

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

Drug: Ropivacaine 0.5% 20 mLs

Adductor canal block

ACTIVE COMPARATOR

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

Drug: Ropivacaine 0.5% 20 mLs

Interventions

Ropivacaine 0.5% 20 mLsDRUG

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.

Also known as: Naropine, Naropin
Adductor canal blockLocal infiltration analgesia

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction

You may not qualify if:

  • peripheral neuropathy
  • pre-existing femoral neuropathy
  • diabetes mellitus
  • alcoholism
  • drug addiction
  • cancer with chemotherapy
  • chronic pain state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 31130273DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Eric Albrecht, PD Dr

    CHUV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Regional Anaesthesia

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 17, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 7, 2018

Record last verified: 2018-05

Locations

CH(1)