ObesityNCT02033265
Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity
An observational study of Obesity and Morbid Obesity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Morbid Obesity
- What is being tested?
- Brachial plexus block
- Type of treatment
- Surgery or procedure
- How many people
- 249 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perineural Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity on Block Performance Time, Failure Rate and Incidence of Acute Complications
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.
Read the 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.
- Conditions
- Obesity, Morbid Obesity
- Being tested
- Brachial plexus block
- Keywords
- Ultrasound-guided Axillary Brachial Plexus Block, Obesity, Performance time, Failure rate, Acute complications
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachial plexus blockProcedure or surgery
Also called Axillary block
Ultrasound guided axillary brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block success rate at 30 minutes
Measured: 30 minutes after block performance
Secondary outcomes (2)
Block performance time
Measured: Immediate
Incidence of acute complications
Measured: Immediate and 48 hours after block performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shalini Dhir, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shalini Dhir, FRCPC, Principal investigator, Lawson Health Research Institute & Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033265
- Sponsor's protocol ID
- IRB00000940
- Status last verified
- Jul 2019
- First submitted
- 9 Jan 2014
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity on Block Performance Time, Failure Rate and Incidence of Acute Complications
- ClinicalTrials.gov ID
- NCT02033265
- Acronym / sponsor ID
- IRB00000940
- Conditions
- Obesity, Morbid Obesity
- Keywords
- Ultrasound-guided Axillary Brachial Plexus Block, Obesity, Performance time, Failure rate, Acute complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with BMI less than 30 kg/m2 | – | Procedure: Brachial plexus blockPatients 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. |
| Patients with BMI 30 or above | – | Procedure: Brachial plexus blockPatients 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brachial plexus blockAlso: Axillary blockUltrasound guided axillary brachial plexus block | Procedure or surgery | Patients with BMI 30 or above, Patients with BMI less than 30 kg/m2 |
Primary outcome
Block success rate at 30 minutes
Time frame: 30 minutes after block performance
2 secondary outcomes
Block performance time
Time frame: Immediate
Incidence of acute complications
Time frame: Immediate and 48 hours after block performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Dhir, FRCPC principal investigator
Lawson Health Research Institute & Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Morbid Obesity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block success rate at 30 minutes (time frame: 30 minutes after block performance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.