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

Regional Anesthesia Morbidity Clinical Trial

Official title:

Postoperative Analgesic Efficacy of Local Infiltration Analgesia Versus Adductor Canal Block After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Double-blinded Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524652
• Other study ID #: CER 193-15
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: March 2018

Study information

• Verified date: May 2018
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Infiltration
• Regional Anesthesia Morbidity
• Rupture
• Rupture of Anterior Cruciate Ligament

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption (mg)		24 h postoperatively
Secondary	Total morphine consumption (mg)		2 h postoperatively
Secondary	Total morphine consumption (mg)		48 h postoperatively
Secondary	Total morphine consumption (mg)		72 h postoperatively
Secondary	Pain scores (numeric rating scale, 0-10) at rest and on movement		2 h postoperatively
Secondary	Pain scores (numeric rating scale, 0-10) at rest and on movement		12 h postoperatively
Secondary	Pain scores (numeric rating scale, 0-10) at rest and on movement		24 h postoperatively
Secondary	Pain scores (numeric rating scale, 0-10) at rest and on movement		36 h postoperatively
Secondary	Pain scores (numeric rating scale, 0-10) at rest and on movement		48 h postoperatively
Secondary	Pain scores (numeric rating scale, 0-10) at rest and on movement		60 h postoperatively
Secondary	Pain scores (numeric rating scale, 0-10) at rest and on movement		72 h postoperatively
Secondary	Postoperative nausea and vomiting (yes/no)		24 h postoperatively
Secondary	Postoperative nausea and vomiting (yes/no)		48 h postoperatively
Secondary	Postoperative nausea and vomiting (yes/no)		72 h postoperatively
Secondary	Pruritus (yes/no)		24 h postoperatively
Secondary	Pruritus (yes/no)		48 h postoperatively
Secondary	Pruritus (yes/no)		72 h postoperatively
Secondary	Active flexion	Flexion of the knee by the patient measured in degrees	24 h postoperatively
Secondary	Active flexion	Flexion of the knee by the patient measured in degrees	48 h postoperatively
Secondary	Active flexion	Flexion of the knee by the patient measured in degrees	72 h postoperatively
Secondary	Quadriceps muscle strength (numeric scale, 1-5)		24 h postoperatively
Secondary	Quadriceps muscle strength (numeric scale, 1-5)		48 h postoperatively
Secondary	Quadriceps muscle strength (numeric scale, 1-5)		72 h postoperatively
Secondary	Distance walked (meters)		24 h postoperatively
Secondary	Distance walked (meters)		48 h postoperatively
Secondary	Distance walked (meters)		72 h postoperatively
Secondary	Anterior Cruciate Ligament - Return to Sport after Injury scale		4 months postoperatively
Secondary	Anterior cruciate ligament -Return to Sport after Injury scale		8 months postoperatively
Secondary	International Knee Documentation Committee score		4 months postoperatively
Secondary	International Knee Documentation Committee score		8 months postoperatively