PainNCT01968824
Brachial Plexus Block in Post-Op Pain Control After Distal Upper Extremity Fracture: A Prospective Randomized Study
A study testing Brachial Plexus Nerve Block in people with Pain, run by NYU Langone Health at 1 site in United States.
Trial summary
Despite the plethora of literature suggesting that regional blockade provides adequate andimproved postoperative pain control, function and improved intraoperative and postoperative safety in proximal upper extremity surgery, little is known of its benefits for the treatment of forearm and distal radius fractures . Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Brachial Plexus Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jul 2016
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients at least 18 years old.
- Male or Female
- All racial and ethnic groups
- Fractures and fracture/dislocations of the elbow, forearm, wrist and hand
- Montaggia and Galleazzi variants
- Patients who opt for surgical treatment of their fractures.
- Patients who consent to be randomized.
- Patients who are willing to follow-up for a minimum of 52 weeks.
Who cannot join
- Patients younger than 18 years old.
- Patients who are unwilling to follow-up for a minimum of 52 weeks.
- Limitation in upper extremity function that would affect outcome scoring
- Neurologic condition that could interfere with pain sensation
- Patients with a contraindication to one of the anesthesia protocols
- Patients who refuse a specific anesthesia protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10003
About this study
Official title: Efficacy of Brachial Plexus Block in Post-Operative Pain Control After Distal Upper Extremity Fracture: A Prospective Randomized Study
Despite the plethora of literature suggesting that regional blockade provides adequate andimproved postoperative pain control, function and improved intraoperative and postoperative safety in proximal upper extremity surgery, little is known of its benefits for the treatment of forearm and distal radius fractures . The purpose of this randomized, prospective, study is to determine if brachial plexus blockade with general anesthesia is superior to general anesthesia alone in immediate and long-term pain control in patients undergoing operative fixation of distal upper extremity fractures.
Read the detailed description
The purpose of this study is to compare two (2) different types of anesthesia treatments that are used during surgery for broken arms for post-surgery pain relief. One group will receive general anesthesia (state of total unconsciousness) the other group will get sedation (medicine injected into patient's vein that helps patient fall asleep), and a nerve block (injection of anesthetic drug into the nerves going to patient's arm in order to make patient's arm numb).
Both forms of anesthesia are used for a variety of surgeries to the arm including shoulder and elbow surgeries. Currently it is thought that there are advantages and disadvantages to both types. The advantage of not using the nerve block in addition to general anesthesia (current standard or care) is that it decreases the potential risk for bleeding, infection and nerve injury. Alternatively, the advantage of using the nerve block with sedation (research-related procedure) is that it can potentially offer better post-operative pain control. This study will examine whether there is added benefit with the addition of nerve block for anesthesia for decreasing pain after surgical treatment of lower arm fractures.
- Conditions
- Pain
- Being tested
- Brachial Plexus Nerve Block
- Keywords
- pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachial Plexus Nerve BlockProcedure or surgery
The brachial plexus will be visualized under ultrasound and a 22 gauge, 3.5 inch needle will be used. 20 cc of bupivicaine will be injected around the brachial plexus after confirming negative aspiration every 5 cc
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | No intervention | general anesthesia only |
| Brachial Plexus Nerve Block | Experimental | brachial plexus nerve block Receives: Procedure: Brachial Plexus Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Pain
post-operative pain will be measured at various time points
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nirmal C Tejwani, MD, Principal investigator, NYU Hospital for Joint Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968824
- Sponsor's protocol ID
- S12-02386
- Status last verified
- Jan 2017
- First submitted
- 14 Oct 2013
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Brachial Plexus Block in Post-Operative Pain Control After Distal Upper Extremity Fracture: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01968824
- Acronym / sponsor ID
- S12-02386
- Conditions
- Pain
- Keywords
- pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Oct 2013 (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.
Despite the plethora of literature suggesting that regional blockade provides adequate andimproved postoperative pain control, function and improved intraoperative and postoperative safety in proximal upper extremity surgery, little is known of its benefits for the treatment of forearm and distal radius fractures . The purpose of this randomized, prospective, study is to determine if brachial plexus blockade with general anesthesia is superior to general anesthesia alone in immediate and long-term pain control in patients undergoing operative fixation of distal upper extremity fractures.
Detailed description
The purpose of this study is to compare two (2) different types of anesthesia treatments that are used during surgery for broken arms for post-surgery pain relief. One group will receive general anesthesia (state of total unconsciousness) the other group will get sedation (medicine injected into patient's vein that helps patient fall asleep), and a nerve block (injection of anesthetic drug into the nerves going to patient's arm in order to make patient's arm numb).
Both forms of anesthesia are used for a variety of surgeries to the arm including shoulder and elbow surgeries. Currently it is thought that there are advantages and disadvantages to both types. The advantage of not using the nerve block in addition to general anesthesia (current standard or care) is that it decreases the potential risk for bleeding, infection and nerve injury. Alternatively, the advantage of using the nerve block with sedation (research-related procedure) is that it can potentially offer better post-operative pain control. This study will examine whether there is added benefit with the addition of nerve block for anesthesia for decreasing pain after surgical treatment of lower arm fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | No intervention | –general anesthesia only |
| Brachial Plexus Nerve Block | Experimental | Procedure: Brachial Plexus Nerve Blockbrachial plexus nerve block |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients at least 18 years old.
- Male or Female
- All racial and ethnic groups
- Fractures and fracture/dislocations of the elbow, forearm, wrist and hand
- Montaggia and Galleazzi variants
Key exclusion criteria (6 listed)
- Patients younger than 18 years old.
- Patients who are unwilling to follow-up for a minimum of 52 weeks.
- Limitation in upper extremity function that would affect outcome scoring
- Neurologic condition that could interfere with pain sensation
- Patients with a contraindication to one of the anesthesia protocols
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 Nerve BlockThe brachial plexus will be visualized under ultrasound and a 22 gauge, 3.5 inch needle will be used. 20 cc of bupivicaine will be injected around the brachial plexus after confirming negative aspiration every 5 cc | Procedure or surgery | Brachial Plexus Nerve Block |
Primary outcome
Post-Operative Pain
Time frame: 2 weeks
post-operative pain will be measured at various time points
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 23 Jan 2017.
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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.
Nirmal C Tejwani, MD principal investigator
NYU Hospital for Joint Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachial Plexus Nerve Block in people with Pain, run by NYU Langone Health at 1 site in United States.
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 8 inclusion and 6 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 23 Jan 2017. 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 United States. 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?
Post-Operative Pain (time frame: 2 weeks). 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 23 Jan 2017.