Trial record 3 of 1320 for:    Open Studies | "Obesity"

Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Shalini Dhir, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT02033265
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Morbid Obesity
Procedure: Brachial plexus block

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Perineural Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity on Block Performance Time, Failure Rate and Incidence of Acute Complications

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Block success rate at 30 minutes [ Time Frame: 30 minutes after block performance ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Block performance time [ Time Frame: Immediate ] [ Designated as safety issue: No ]
  • Incidence of acute complications [ Time Frame: Immediate and 48 hours after block performance ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Ultrasound guided axillary brachial plexus block
Other Name: Axillary 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
Ultrasound guided axillary brachial plexus block
Other Name: Axillary block

Detailed Description:

The prevalence of obesity is increasing throughout the world. General Anesthesia for obese patients is associated with increased risk of difficult/failed tracheal intubation and aspiration of gastric contents. These life-threatening complications can be avoided by use of regional anesthesia. Other potential advantages of regional anesthesia include improved pain control, less incidence of nausea and vomiting, early ambulation, decreased pulmonary complications, shorter hospital stay. On the other hand, regional anesthesia in obese patients can be challenging because of loss in anatomical landmarks. However, the availability of high-resolution ultrasound imaging has decreased the reliance on anatomical landmarks as the vascular, nervous and musculoskeletal structures can be directly visualized. Ultrasound imaging also allows real time needle visualization and local anesthetic can be deposited more precisely allowing faster onset anesthesia and reduced incidence of complications. Brachial plexus can be anaesthetized at various levels along its course to provide anesthesia for elbow, forearm and hand surgery. Axillary region is ideal site for targeting brachial plexus in obese patients as the plexus is superficial in this region and the likelihood of causing serious complications (e.g. pleural puncture) is low. Study of 188 patients by Chan et al showed that use of ultrasound increases the success rate of axillary brachial plexus block from 63% to 80% when compared with nerve stimulation technique. A recent study (Hanouz et al) showed that obesity increases the failure rate and immediate complications of axillary brachial plexus block but ultrasound was not used for performing the block. In current era, we consider ultrasound-guidance as a standard of care. We hypothesize that the block performance time, success rate and incidence of acute complications are similar in obese and non-obese patients when ultrasound-guidance is used to perform brachial plexus block in axillary region.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Patients with associated significant cardiac and respiratory disease (ASA status 4/5)
  2. Patients with coexisting hematological disorder or with deranged coagulation parameters.
  3. Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
  4. Psychiatric illnesses
  5. Emergency surgery
  6. Lack of informed consent.
  7. Allergy to any of the drugs used in the study
  8. Contraindications to brachial plexus block
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033265

Contacts
Contact: Shalini Dhir, MD +1(519) 646-6100 shalini.dhir@sjhc.london.on.ca
Contact: Vishal Uppal, FRCA +1(519) 859-9400 vishal.uppal3@gmail.com

Locations
Canada, Ontario
St. Joseph's Health Care Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Shalini Dhir, MD    +1 (519) 646-6100    shalini.dhir@sjhc.london.on.ca   
Contact: Vishal Uppal, FRCA    5198599400    vishal.uppal3@gmail.com   
Principal Investigator: Shilini Dhir, MD         
Sub-Investigator: Vishal Uppal, FRCA         
Sub-Investigator: Rakesh Sondekoppam, MD         
Sub-Investigator: Sugantha Ganapathy, FRCPC         
Sub-Investigator: Maria Lopera, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Shalini Dhir, FRCPC Lawson Health Research Institute & Western University
  More Information

No publications provided

Responsible Party: Shalini Dhir, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02033265     History of Changes
Other Study ID Numbers: IRB00000940
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Ultrasound-guided Axillary Brachial Plexus Block
Obesity
Performance time
Failure rate
Acute complications

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014