Obesity, Ultrasound Guided Axillary Brachial Plexus BlockNCT02825888
Perineural Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity on Block Performance Time, Failure Rate and Incidence of Acute Complications (Observational Study)
An observational study of Obesity, Ultrasound Guided Axillary Brachial Plexus Block, run by Dr. Vishal Uppal at 2 sites in Canada.
Trial summary
Title of Research Program: Ultrasound Guided Axillary Brachial Plexus Block: Influence of Obesity on Block Failure Rate, Performance Time and Incidence of Acute Complications- A prospective observational cohort study Background: Axillary brachial plexus (ABP) block is commonly performed as the primary anesthetic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Ultrasound Guided Axillary Brachial Plexus Block
- How many people
- 249 participants
- Where
- 2 sitesCanada
- Study dates
- 16 Aug 2013to 30 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: Subjects booked for upper limb surgery who have been assessed as potential recipients of PNB during routine preoperative assessment for an expression of interest in study participation.
Who may be able to join
- Age 18 to 75 years, scheduled to undergo elbow, forearm and hand surgery; Brachial plexus block is offered to patients as a part of planned routine care; American Society of Anesthesiologists' (ASA) status I to III.
Who cannot join
- Patients with associated significant cardiac and respiratory disease (ASA status IV/V); Any pre-existing medical disorder that would contraindicate an Axillary brachial plexus block i.e. Known hematological disorder or with deranged coagulation parameters, Major organ dysfunction such as hepatic and renal failure, Neuropathy; Allergy to any of the drugs used in the study; Contraindications to brachial plexus block; Cognitive dysfunction that may impair consent or subject ability to complete data collection
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Nova Scotia Health Authority (NSHA) Halifax Infirmary (HI) site, Halifax NS
Halifax
St. Joseph's Health Care (SJHC), London-Ontario
London
About this study
Title of Research Program: Ultrasound Guided Axillary Brachial Plexus Block: Influence of Obesity on Block Failure Rate, Performance Time and Incidence of Acute Complications- A prospective observational cohort study
Background: Axillary brachial plexus (ABP) block is commonly performed as the primary anesthetic technique to provide surgical anesthesia and postoperative analgesia for elbow, forearm and hand surgery. Compared to general anesthesia, ABP blocks have been shown to result in better pain relief, less nausea and vomiting, shortened length of hospital stay, decreased side effects of opioids painkillers and better patient satisfaction. These beneficial effects of ABP blocks are particularly useful for patients who are overweight or obese as this cohort is at a higher risk of experiencing complications from general anesthesia. Traditionally, nerve blocks have been described technically challenging in obese patients. This may not be true now with availability of high-resolution ultrasonography (US). US imaging also allows doctors the ability to visualize the needle "live" to allow for more accurate needle placement. This allows local anesthetic to be placed more precisely resulting in faster onset anesthesia, decreased local anesthetic drug dosages, reduced complications and higher success rate. Ultrasound guidance has not been used for performing ABP block in previous studies in obese patients.
Read more
Hypothesis: We hypothesize that the block failure rate is no worse in obese compared to non-obese patients when US guidance is used to perform ABP blocks.
Specific Objectives: The primary objective of this study is to evaluate whether obese patients receiving US guided ABP block as their primary anesthetic modality have a block success rate (defined by a Composite Score ≥ 14 at 30 minutes) worse than their non-obese peers. The secondary objective is to evaluate time parameters around ABP performance, incidence of complications and patient satisfaction.
Methods: This study will be conducted as an observational quasi-experimental multicenter trial at St. Joseph's Health Care (SJHC), London, ON and the Nova Scotia Health Authority (NSHA) Halifax Infirmary (HI) site, Halifax NS. There will be 250 patients taking part in this study. One hundred and fifty patients have already completed the study in Ontario. The duration of the study at the Halifax Infirmary is 10 months. Healthy patients (aged 18-75 years) scheduled to undergo elbow/ forearm/ or hand surgery will be invited to volunteer in this observational study. A study investigator or resident under direction supervision of a study investigator will perform the ABP block. There is NO experimental drug or treatment in this study. Patient demographics including age, sex, arm circumference, height, weight and Body Mass Index will be recorded. Nerve blocks will be performed in a designated area near operating rooms called the block room. US will be used for identification of the nerves supplying the arm and an ABP block will be performed with a total volume of 30 mL of 0.5% ropivacaine according to a standardized procedure. Measurements of sensory and motor blockage will be recorded every 5 minutes for 30 minutes following the ABP block. Block success will be measured and is defined as a score of ≥ 14 on the Composite Score (CS) within 30 minutes of ABP block completion. According to routine care, all patients will receive a phone call from the investigators 24-48 hours after surgery to inquire about complications. The study follows non-inferiority design to show that the success rate in the obese group is not worse than the non-obese when anesthetized. In non-inferiority trials, both intention to treat and per-protocol analysis are recommended; both approaches should support non-inferiority The student's t-test (unpaired, two tailed) will be used for comparison of the means of continuous, normally distributed data or Mann-Whitney U test as appropriate. Categorical data (success rate, complication rate) are to be analyzed using χ2 test or Fisher's exact test, as appropriate. An interim analysis will not be conducted and set at 0.05 for significance and 95% confidence intervals.
Significance/ Importance: This study would provide anesthesiologists additional information to inform their clinical decision-making when dealing with obese patients. To date there are no publications or any registered trials exploring the success rates and technical aspects of ABP blockade in obese patients using US guidance technology for block performance. Therefore, this study is novel and timely for the patient groups.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-obese | Body Mass index less than 30 kg/m2 | |
| Obese | Body Mass index more than 30 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate as measured by composite score
Measured: 30 minutes after performance of block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start16 Aug 2013
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, Ultrasound Guided Axillary Brachial Plexus BlockStudies of the same condition, open and under way.
- 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
- Dr. Vishal Uppal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Vishal Uppal, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825888
- Sponsor's protocol ID
- 103673
- Status last verified
- Jul 2019
- First submitted
- 4 Jul 2016
- Last updated
- 16 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 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 (Observational Study)
- ClinicalTrials.gov ID
- NCT02825888
- Acronym / sponsor ID
- 103673
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Dr. Vishal UppalUniversity, hospital or other
- Study start
- 16 Aug 2013 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 7 Jul 2016 (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.
Title of Research Program: Ultrasound Guided Axillary Brachial Plexus Block: Influence of Obesity on Block Failure Rate, Performance Time and Incidence of Acute Complications- A prospective observational cohort study
Background: Axillary brachial plexus (ABP) block is commonly performed as the primary anesthetic technique to provide surgical anesthesia and postoperative analgesia for elbow, forearm and hand surgery. Compared to general anesthesia, ABP blocks have been shown to result in better pain relief, less nausea and vomiting, shortened length of hospital stay, decreased side effects of opioids painkillers and better patient satisfaction. These beneficial effects of ABP blocks are particularly useful for patients who are overweight or obese as this cohort is at a higher risk of experiencing complications from general anesthesia. Traditionally, nerve blocks have been described technically challenging in obese patients. This may not be true now with availability of high-resolution ultrasonography (US). US imaging also allows doctors the ability to visualize the needle "live" to allow for more accurate needle placement. This allows local anesthetic to be placed more precisely resulting in faster onset anesthesia, decreased local anesthetic drug dosages, reduced complications and higher success rate. Ultrasound guidance has not been used for performing ABP block in previous studies in obese patients.
Hypothesis: We hypothesize that the block failure rate is no worse in obese compared to non-obese patients when US guidance is used to perform ABP blocks.
Specific Objectives: The primary objective of this study is to evaluate whether obese patients receiving US guided ABP block as their primary anesthetic modality have a block success rate (defined by a Composite Score ≥ 14 at 30 minutes) worse than their non-obese peers. The secondary objective is to evaluate time parameters around ABP performance, incidence of complications and patient satisfaction.
Methods: This study will be conducted as an observational quasi-experimental multicenter trial at St. Joseph's Health Care (SJHC), London, ON and the Nova Scotia Health Authority (NSHA) Halifax Infirmary (HI) site, Halifax NS. There will be 250 patients taking part in this study. One hundred and fifty patients have already completed the study in Ontario. The duration of the study at the Halifax Infirmary is 10 months. Healthy patients (aged 18-75 years) scheduled to undergo elbow/ forearm/ or hand surgery will be invited to volunteer in this observational study. A study investigator or resident under direction supervision of a study investigator will perform the ABP block. There is NO experimental drug or treatment in this study. Patient demographics including age, sex, arm circumference, height, weight and Body Mass Index will be recorded. Nerve blocks will be performed in a designated area near operating rooms called the block room. US will be used for identification of the nerves supplying the arm and an ABP block will be performed with a total volume of 30 mL of 0.5% ropivacaine according to a standardized procedure. Measurements of sensory and motor blockage will be recorded every 5 minutes for 30 minutes following the ABP block. Block success will be measured and is defined as a score of ≥ 14 on the Composite Score (CS) within 30 minutes of ABP block completion. According to routine care, all patients will receive a phone call from the investigators 24-48 hours after surgery to inquire about complications. The study follows non-inferiority design to show that the success rate in the obese group is not worse than the non-obese when anesthetized. In non-inferiority trials, both intention to treat and per-protocol analysis are recommended; both approaches should support non-inferiority The student's t-test (unpaired, two tailed) will be used for comparison of the means of continuous, normally distributed data or Mann-Whitney U test as appropriate. Categorical data (success rate, complication rate) are to be analyzed using χ2 test or Fisher's exact test, as appropriate. An interim analysis will not be conducted and set at 0.05 for significance and 95% confidence intervals.
Significance/ Importance: This study would provide anesthesiologists additional information to inform their clinical decision-making when dealing with obese patients. To date there are no publications or any registered trials exploring the success rates and technical aspects of ABP blockade in obese patients using US guidance technology for block performance. Therefore, this study is novel and timely for the patient groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-obese | – | –Body Mass index less than 30 kg/m2 |
| Obese | – | –Body Mass index more than 30 kg/m2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects booked for upper limb surgery who have been assessed as potential recipients of PNB during routine preoperative assessment for an expression of interest in study participation.
Key inclusion criteria (1 listed)
- Age 18 to 75 years, scheduled to undergo elbow, forearm and hand surgery; Brachial plexus block is offered to patients as a part of planned routine care; American Society of Anesthesiologists' (ASA) status I to III.
Key exclusion criteria (1 listed)
- Patients with associated significant cardiac and respiratory disease (ASA status IV/V); Any pre-existing medical disorder that would contraindicate an Axillary brachial plexus block i.e. Known hematological disorder or with deranged coagulation parameters, Major organ dysfunction such as hepatic and renal failure, Neuropathy; Allergy to any of the drugs used in the study; Contraindications to brachial plexus block; Cognitive dysfunction that may impair consent or subject ability to complete data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success rate as measured by composite score
Time frame: 30 minutes after performance of block
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 16 Jul 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Ultrasound Guided Axillary Brachial Plexus Block, run by Dr. Vishal Uppal at 2 sites 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 1 inclusion and 1 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 16 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 2 sites 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?
Success rate as measured by composite score (time frame: 30 minutes after performance of block). 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 16 Jul 2019.