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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02524652
Date of registration:	06/08/2015
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Universitaire Vaudois
Public title:	Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction
Scientific title:	Postoperative Analgesic Efficacy of Local Infiltration Analgesia Versus Adductor Canal Block After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Double-blinded Trial
Date of first enrolment:	September 2015
Target sample size:	104
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02524652
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
Phase:	Phase 4

Countries of recruitment
Switzerland

Contacts

Name:	Eric Albrecht, PD Dr
Address:
Telephone:
Email:
Affiliation:	CHUV

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Regional Anesthesia Morbidity

Infiltration

Rupture of Anterior Cruciate Ligament

Intervention(s)

Drug: Ropivacaine 0.5% 20 mLs

Primary Outcome(s)

Total morphine consumption (mg) [Time Frame: 24 h postoperatively]

Secondary Outcome(s)

Anterior cruciate ligament -Return to Sport after Injury scale [Time Frame: 8 months postoperatively]

Quadriceps muscle strength (numeric scale, 1-5) [Time Frame: 72 h postoperatively]

International Knee Documentation Committee score [Time Frame: 4 months postoperatively]

Pain scores (numeric rating scale, 0-10) at rest and on movement [Time Frame: 60 h postoperatively]

Pain scores (numeric rating scale, 0-10) at rest and on movement [Time Frame: 72 h postoperatively]

Pruritus (yes/no) [Time Frame: 72 h postoperatively]

International Knee Documentation Committee score [Time Frame: 8 months postoperatively]

Pain scores (numeric rating scale, 0-10) at rest and on movement [Time Frame: 12 h postoperatively]

Active flexion [Time Frame: 48 h postoperatively]

Postoperative nausea and vomiting (yes/no) [Time Frame: 48 h postoperatively]

Active flexion [Time Frame: 72 h postoperatively]

Distance walked (meters) [Time Frame: 24 h postoperatively]

Distance walked (meters) [Time Frame: 48 h postoperatively]

Pain scores (numeric rating scale, 0-10) at rest and on movement [Time Frame: 2 h postoperatively]

Active flexion [Time Frame: 24 h postoperatively]

Anterior Cruciate Ligament - Return to Sport after Injury scale [Time Frame: 4 months postoperatively]

Pain scores (numeric rating scale, 0-10) at rest and on movement [Time Frame: 36 h postoperatively]

Postoperative nausea and vomiting (yes/no) [Time Frame: 72 h postoperatively]

Total morphine consumption (mg) [Time Frame: 2 h postoperatively]

Quadriceps muscle strength (numeric scale, 1-5) [Time Frame: 24 h postoperatively]

Distance walked (meters) [Time Frame: 72 h postoperatively]

Pruritus (yes/no) [Time Frame: 24 h postoperatively]

Total morphine consumption (mg) [Time Frame: 72 h postoperatively]

Pain scores (numeric rating scale, 0-10) at rest and on movement [Time Frame: 24 h postoperatively]

Quadriceps muscle strength (numeric scale, 1-5) [Time Frame: 48 h postoperatively]

Pain scores (numeric rating scale, 0-10) at rest and on movement [Time Frame: 48 h postoperatively]

Postoperative nausea and vomiting (yes/no) [Time Frame: 24 h postoperatively]

Pruritus (yes/no) [Time Frame: 48 h postoperatively]

Total morphine consumption (mg) [Time Frame: 48 h postoperatively]

Secondary ID(s)

CER 193-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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