Post Operative PainPhase 4NCT04540848
Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
A Phase 4 study testing Group A (Exparel plus supraclavicular block), Group B (Bupivacaine HCL plus supraclavicular block) and Group C(supraclavicular block only) in people with Post Operative Pain, run by The University of Texas Health Science Center, Houston.
Trial summary
The purpose of this study is to see if Exparel, used intraoperatively by injecting at the surgical site, followed by a Supraclavicular nerve block with bupivacaine in the recovery room, will provide better pain scores for patients at 24 and 48 hours post operatively than, 1)Bupivacaine Hydrochloride (HCL) injection at… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Group A (Exparel plus supraclavicular block), Group B (Bupivacaine HCL plus supraclavicular block) and Group C(supraclavicular block only)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 20 Nov 2021
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- distal radius fractures
- undergoing Open reduction internal fixation (ORIF) at Lyndon B Johnson Ambulatory Surgical Center (LBJ ASC)
Who cannot join
- pregnancy
- history of chronic pain conditions
- currently taking opioids
About this study
The purpose of this study is to see if Exparel, used intraoperatively by injecting at the surgical site, followed by a Supraclavicular nerve block with bupivacaine in the recovery room, will provide better pain scores for patients at 24 and 48 hours post operatively than, 1)Bupivacaine Hydrochloride (HCL) injection at the surgical site, with a supraclavicular block in Post-anesthesia care unit(PACU), or 2)a supraclavicular block in PACU without any kind of injection at the surgical site.
- Conditions
- Post Operative Pain
- Being tested
- Group A (Exparel plus supraclavicular block), Group B (Bupivacaine HCL plus supraclavicular block), Group C(supraclavicular block only)
- Keywords
- Brachial plexus block, Multimodal pain control for Distal Radius surgery, Exparel, Bupivacaine, Distal Radius Pain Control, Post operative pain Control, Supraclavicular nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (Exparel plus supraclavicular block)Drug
Patients will receive 20 cc (266 mg) of Exparel injected in the distal radius area and a supraclavicular block in the recovery room.The supraclavicular blocks will be ultrasound guided and consist of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket".
Group B (Bupivacaine HCL plus supraclavicular block)Drug
Patients will receive 20 cc of Bupivacaine 0.25% (50mg) in the distal radius area.In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket".
Group C(supraclavicular block only)Drug
In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket".
| Study group | Role | What they receive |
|---|---|---|
| Exparel plus supraclavicular block | Experimental | Not described Receives: Drug: Group A (Exparel plus supraclavicular block) |
| Bupivacaine HCL plus supraclavicular block | Active comparator | Not described Receives: Drug: Group B (Bupivacaine HCL plus supraclavicular block) |
| supraclavicular block only | Active comparator | Not described Receives: Drug: Group C(supraclavicular block only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
Measured: 24 hours post treatment
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
Measured: 48 hours post treatment
Secondary outcomes (6)
Number of patients who presented to Emergency room following surgery for pain control
Measured: 24 hours post surgery
Number of patients who presented to Emergency room following surgery for pain control
Measured: 48 hours post surgery
Number of over the counter(OTC) pain medications consumed by the patient
Measured: 24 hours post surgery
Number of OTC pain medications consumed by the patient
Measured: 48 hours post surgery
Number of prescription opioid medications consumed by the patient
Measured: 24 hours post surgery
Number of prescription opioid medications consumed by the patient
Measured: 48 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Mar 2021 (estimated)
- Primary completion20 Nov 2021 (estimated)
- Study completion20 Nov 2021 (estimated)
Why it stopped: Lack of ability to communicate with the study population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erikka L Washington, The University of Texas Health Science Center, Houston
- Investigators
- Erikka L Washington, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540848
- Sponsor's protocol ID
- HSC-MS-20-0430
- Status last verified
- Oct 2021
- First submitted
- 31 Aug 2020
- Last updated
- 29 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
- ClinicalTrials.gov ID
- NCT04540848
- Acronym / sponsor ID
- HSC-MS-20-0430
- Conditions
- Post Operative Pain
- Keywords
- Brachial plexus block, Multimodal pain control for Distal Radius surgery, Exparel, Bupivacaine, Distal Radius Pain Control, Post operative pain Control, Supraclavicular nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of ability to communicate with the study population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 20 Nov 2021 (estimated)
- Study completion
- 20 Nov 2021 (estimated)
- First posted
- 7 Sep 2020 (actual)
- 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.
The purpose of this study is to see if Exparel, used intraoperatively by injecting at the surgical site, followed by a Supraclavicular nerve block with bupivacaine in the recovery room, will provide better pain scores for patients at 24 and 48 hours post operatively than, 1)Bupivacaine Hydrochloride (HCL) injection at the surgical site, with a supraclavicular block in Post-anesthesia care unit(PACU), or 2)a supraclavicular block in PACU without any kind of injection at the surgical site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exparel plus supraclavicular block | Experimental | Drug: Group A (Exparel plus supraclavicular block) |
| Bupivacaine HCL plus supraclavicular block | Active comparator | Drug: Group B (Bupivacaine HCL plus supraclavicular block) |
| supraclavicular block only | Active comparator | Drug: Group C(supraclavicular block only) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- distal radius fractures
- undergoing Open reduction internal fixation (ORIF) at Lyndon B Johnson Ambulatory Surgical Center (LBJ ASC)
Key exclusion criteria (3 listed)
- pregnancy
- history of chronic pain conditions
- currently taking opioids
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 |
|---|---|---|
| Group A (Exparel plus supraclavicular block)Patients will receive 20 cc (266 mg) of Exparel injected in the distal radius area and a supraclavicular block in the recovery room.The supraclavicular blocks will be ultrasound guided and consist of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket". | Drug | Exparel plus supraclavicular block |
| Group B (Bupivacaine HCL plus supraclavicular block)Patients will receive 20 cc of Bupivacaine 0.25% (50mg) in the distal radius area.In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket". | Drug | Bupivacaine HCL plus supraclavicular block |
| Group C(supraclavicular block only)In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket". | Drug | supraclavicular block only |
Primary outcome
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Time frame: 24 hours post treatment
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Time frame: 48 hours post treatment
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
6 secondary outcomes
Number of patients who presented to Emergency room following surgery for pain control
Time frame: 24 hours post surgery
Number of patients who presented to Emergency room following surgery for pain control
Time frame: 48 hours post surgery
Number of over the counter(OTC) pain medications consumed by the patient
Time frame: 24 hours post surgery
Number of OTC pain medications consumed by the patient
Time frame: 48 hours post surgery
Number of prescription opioid medications consumed by the patient
Time frame: 24 hours post surgery
Number of prescription opioid medications consumed by the patient
Time frame: 48 hours post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Erikka L Washington, MD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group A (Exparel plus supraclavicular block), Group B (Bupivacaine HCL plus supraclavicular block) and Group C(supraclavicular block only) in people with Post Operative Pain, run by The University of Texas Health Science Center, Houston.
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 3 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: withdrawn, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) (time frame: 24 hours post treatment). The study lists 2 primary outcomes in all. 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 29 Oct 2021.