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

Primary Purpose

Rupture of Anterior Cruciate Ligament, Infiltration, Regional Anesthesia Morbidity

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Ropivacaine 0.5% 20 mLs
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rupture of Anterior Cruciate Ligament

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Local infiltration analgesia

Adductor canal block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total morphine consumption (mg)

Secondary Outcome Measures

Total morphine consumption (mg)
Total morphine consumption (mg)
Total morphine consumption (mg)
Pain scores (numeric rating scale, 0-10) at rest and on movement
Pain scores (numeric rating scale, 0-10) at rest and on movement
Pain scores (numeric rating scale, 0-10) at rest and on movement
Pain scores (numeric rating scale, 0-10) at rest and on movement
Pain scores (numeric rating scale, 0-10) at rest and on movement
Pain scores (numeric rating scale, 0-10) at rest and on movement
Pain scores (numeric rating scale, 0-10) at rest and on movement
Postoperative nausea and vomiting (yes/no)
Postoperative nausea and vomiting (yes/no)
Postoperative nausea and vomiting (yes/no)
Pruritus (yes/no)
Pruritus (yes/no)
Pruritus (yes/no)
Active flexion
Flexion of the knee by the patient measured in degrees
Active flexion
Flexion of the knee by the patient measured in degrees
Active flexion
Flexion of the knee by the patient measured in degrees
Quadriceps muscle strength (numeric scale, 1-5)
Quadriceps muscle strength (numeric scale, 1-5)
Quadriceps muscle strength (numeric scale, 1-5)
Distance walked (meters)
Distance walked (meters)
Distance walked (meters)
Anterior Cruciate Ligament - Return to Sport after Injury scale
Anterior cruciate ligament -Return to Sport after Injury scale
International Knee Documentation Committee score
International Knee Documentation Committee score

Full Information

First Posted
August 6, 2015
Last Updated
May 4, 2018
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT02524652
Brief Title
Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction
Official Title
Postoperative Analgesic Efficacy of Local Infiltration Analgesia Versus Adductor Canal Block After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Double-blinded Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament, Infiltration, Regional Anesthesia Morbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local infiltration analgesia
Arm Type
Experimental
Arm Description
Infiltration of the knee by the surgeon with local anaesthetics under general anaesthesia.
Arm Title
Adductor canal block
Arm Type
Active Comparator
Arm Description
Injection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist after the surgery, before awaking the patient.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% 20 mLs
Other Intervention Name(s)
Naropine, Naropin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total morphine consumption (mg)
Time Frame
24 h postoperatively
Secondary Outcome Measure Information:
Title
Total morphine consumption (mg)
Time Frame
2 h postoperatively
Title
Total morphine consumption (mg)
Time Frame
48 h postoperatively
Title
Total morphine consumption (mg)
Time Frame
72 h postoperatively
Title
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time Frame
2 h postoperatively
Title
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time Frame
12 h postoperatively
Title
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time Frame
24 h postoperatively
Title
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time Frame
36 h postoperatively
Title
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time Frame
48 h postoperatively
Title
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time Frame
60 h postoperatively
Title
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time Frame
72 h postoperatively
Title
Postoperative nausea and vomiting (yes/no)
Time Frame
24 h postoperatively
Title
Postoperative nausea and vomiting (yes/no)
Time Frame
48 h postoperatively
Title
Postoperative nausea and vomiting (yes/no)
Time Frame
72 h postoperatively
Title
Pruritus (yes/no)
Time Frame
24 h postoperatively
Title
Pruritus (yes/no)
Time Frame
48 h postoperatively
Title
Pruritus (yes/no)
Time Frame
72 h postoperatively
Title
Active flexion
Description
Flexion of the knee by the patient measured in degrees
Time Frame
24 h postoperatively
Title
Active flexion
Description
Flexion of the knee by the patient measured in degrees
Time Frame
48 h postoperatively
Title
Active flexion
Description
Flexion of the knee by the patient measured in degrees
Time Frame
72 h postoperatively
Title
Quadriceps muscle strength (numeric scale, 1-5)
Time Frame
24 h postoperatively
Title
Quadriceps muscle strength (numeric scale, 1-5)
Time Frame
48 h postoperatively
Title
Quadriceps muscle strength (numeric scale, 1-5)
Time Frame
72 h postoperatively
Title
Distance walked (meters)
Time Frame
24 h postoperatively
Title
Distance walked (meters)
Time Frame
48 h postoperatively
Title
Distance walked (meters)
Time Frame
72 h postoperatively
Title
Anterior Cruciate Ligament - Return to Sport after Injury scale
Time Frame
4 months postoperatively
Title
Anterior cruciate ligament -Return to Sport after Injury scale
Time Frame
8 months postoperatively
Title
International Knee Documentation Committee score
Time Frame
4 months postoperatively
Title
International Knee Documentation Committee score
Time Frame
8 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, PD Dr
Organizational Affiliation
CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31130273
Citation
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.
Results Reference
derived

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

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