Recruiting

Lidocaine-Bupivacaine

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT02571699

Conditions

Injuries to the Ankle and Foot

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Subgluteal Nerve Block

Study Details

Brief summary:

The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block.

Conditions

Injuries to the Ankle and Foot

Study ID

NCT02571699

Start date

Mar, 2016

Status verified date

Jun, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 subgluteal region
  • chronic pain syndromes requiring opioid intake at home

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Subgluteal sciatic block

Subgluteal block with similar volume

experimental: Subgluteal block

Subgluteal block with decreasing volume

Interventions

Subgluteal Nerve Block

ultrasound-guided subgluteal sciatic nerve block.

Primary outcome measure

  • success rate [ Time Frame: 0-30 minutes ]

Central Contacts and Locations

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G-1A4

Contacts

De QH Tran, MD, FRCPC

+15149341934de_tran@hotmail.com

Principal Investigator:

De QH Tran, MD, FRCPC

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Jun 13, 2016

Last verified

Jun, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2016-06-13.