NCT02033265

Brief Summary

Axillary brachial plexus block (freezing the nerves in armpit) is commonly performed as a primary anesthetic technique for the elbow/ forearm or hand surgery. These nerves are identified using ultrasound and nerve stimulator (by stimulating the nerves using a small current through the needle). Axillary brachial plexus block has been shown to result in better pain relief, less nausea, vomiting and early discharge from hospital. The use of these nerve blocks have also shown to decrease the duration of hospital stay, decreased side effects of opioids painkillers and better satisfaction scores over the conventional use of intravenous and oral pain medications. These beneficial effects are particularly useful for patients who are overweight or obese. A study by Hauouz et al published in Anesthesia and Analgesia in July 2010 suggests that the success rate of brachial plexus block is lower for obese and overweight patients. However, ultrasound guidance was not used for performing axillary brachial plexus block in this study. We propose that with usage of ultrasound guidance the success rate of brachial plexus block will be similar in obese and non-obese patients. In this study, we want to compare the success rate of axillary brachial plexus block for obese and non-obese patient groups. We would also like to look at performance time, complications and patient satisfaction for our study population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

4.6 years

First QC Date

January 9, 2014

Last Update Submit

July 9, 2019

Conditions

ObesityMorbid Obesity

Keywords

Ultrasound-guided Axillary Brachial Plexus BlockObesityPerformance timeFailure rateAcute complications

Outcome Measures

Primary Outcomes (1)

  • Block success rate at 30 minutes

    30 minutes after block performance

Secondary Outcomes (2)

  • Block performance time

    Immediate

  • Incidence of acute complications

    Immediate and 48 hours after block performance

Study Arms (2)

Patients with BMI less than 30 kg/m2

Patients with BMI less than 30 kg/m2 undergoing surgical procedures on upper limb (elbow, forearm and hand) scheduled to receive ultrasound-guided axillary brachial plexus block as their primary anesthetic modality at SJHC.

Procedure: Brachial plexus block

Patients with BMI 30 or above

Patients with BMI 30 kg/m2 undergoing surgical procedures on upper limb (elbow, forearm and hand) scheduled to receive ultrasound-guided axillary brachial plexus block as their primary anesthetic modality at SJHC

Procedure: Brachial plexus block

Interventions

Brachial plexus blockPROCEDURE

Ultrasound guided axillary brachial plexus block

Also known as: Axillary block
Patients with BMI 30 or abovePatients with BMI less than 30 kg/m2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgical procedures on upper limb (elbow, forearm and hand) scheduled to receive ultrasound-guided axillary brachial plexus block as their primary anesthetic modality at SJHC

You may qualify if:

  • Patients undergoing surgical procedures on upper limb (elbow, forearm and hand) scheduled to receive ultrasound-guided axillary brachial plexus block as their primary anesthetic modality at SJHC
  • American Society of -Anaesthesiologists' (ASA) status I to III

You may not qualify if:

  • Patients with associated significant cardiac and respiratory disease (ASA status 4/5)
  • Patients with coexisting hematological disorder or with deranged coagulation parameters.
  • Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
  • Psychiatric illnesses
  • Emergency surgery
  • Lack of informed consent.
  • Allergy to any of the drugs used in the study
  • Contraindications to brachial plexus block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

ObesityObesity, Morbid

Interventions

Brachial Plexus Block

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Shalini Dhir, FRCPC

    Lawson Health Research Institute & Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 10, 2014

Study Start

September 1, 2013

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

July 11, 2019

Record last verified: 2019-07

Locations

CA(1)