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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02909257
Date of registration: 19/09/2016
Prospective Registration: No
Primary sponsor: University of Chile
Public title: Motor-Sparing Femoral Nerve Block Dose
Scientific title: Minimum Effective Concentration of Bupivacaine for Motor-Sparing Femoral Nerve Block
Date of first enrolment: September 2016
Target sample size: 31
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02909257
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Investigator).  
Phase:  Phase 4
Countries of recruitment
Chile
Contacts
Name:     DE QH TRAN, MD, FRCPC
Address: 
Telephone:
Email:
Affiliation:  McGill University Health Centre/Research Institute of the McGill University Health Centre
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age between 18 and 75 years

- American Society of Anesthesiologists classification 1-3

- Body mass index between 20 and 35

Exclusion Criteria:

- Adults who are unable to give their own consent

- Pre-existing neuropathy (assessed by history and physical examination)

- Coagulopathy (assessed by history and physical examination and, if deemed clinically
necessary, by blood work up i.e. platelets= 100, International Normalized Ratio= 1.4
or partial prothrombin time = 50)

- Renal failure (assessed by history and physical examination and, if deemed clinically
necessary, by blood work up i.e. creatinine = 100)

- Hepatic failure (assessed by history and physical examination and, if deemed
clinically necessary, by blood work up i.e. transaminases = 100)

- Allergy to LA

- Pregnancy

- Prior surgery in the inguinal region

- Chronic pain syndromes requiring opioid intake at home



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Osteoarthritis, Knee
Knee Injuries
Intervention(s)
Drug: Same Bupivacaine Concentration
Drug: Lower Bupivacaine Concentration
Primary Outcome(s)
Minimum Bupivacaine Analgesic concentration preserving quadriceps strength analgesia [Time Frame: 5 months]
Secondary Outcome(s)
Secondary ID(s)
OAIC 823/16
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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