Pain, PostoperativePhase 1CTRNCT03729375
The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release
A Phase 1 study testing 10cc injection of bupivacaine and 20cc injection of bupivacaine in people with Pain, Postoperative and Carpal Tunnel Syndrome, run by University of South Florida at 1 site in United States.
Trial summary
Carpal Tunnel Syndrome patients undergoing carpal tunnel release surgery performed by the PI will receive intra-operative injections of bupivacaine (Marcaine). Two groups of patients will be randomly selected and will receive either 10cc or 20cc of injection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Postoperative, Carpal Tunnel Syndrome
- What is being tested?
- 10cc injection of bupivacaine and 20cc injection of bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2018to 4 Oct 2020
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient must be undergoing carpal tunnel release surgery performed by PI
- EMG or Ultrasound diagnosed carpal tunnel syndrome
Who cannot join
- co-musculoskeletal injuries
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida Department of Orthopaedics
Tampa, Florida, 33612
About this study
Carpal Tunnel Syndrome patients undergoing carpal tunnel release surgery performed by the PI will receive intra-operative injections of bupivacaine (Marcaine). Two groups of patients will be randomly selected and will receive either 10cc or 20cc of injection. Their post-operative pain scores and usage of post-operative pain medication will be recorded and analyzed.
Read the detailed description
This randomized control trial will be conducted at the USF Department of Orthopaedics at the USF Health Morsani Center after receiving approval from the USF Institutional Review Board. Patients will be evaluated Carpal Tunnel Syndrome and screened as candidates for Carpal Tunnel Release surgery, following the inclusion and exclusion criteria. The Medical Record Number (MRN) will be used to randomly assign into treatment interventions. Group 1 and group 2 will receive 10cc and 20cc of intra-operative intra-carpal tunnel anesthetic injection, respectively. Postoperatively, patients will be prescribed an opioid pain medication in congruence with current standard medical practice. Patients will be contacted at 24-hours, 48-hours, 72-hours, and at 2-week clinic follow-up by research staff and will be evaluated for pain levels through the LIKERT scale and pain management through use of prescribed and supplemental pain medications. All data will be analyzed through SPSS v25.
- Conditions
- Pain, Postoperative, Carpal Tunnel Syndrome
- Being tested
- 10cc injection of bupivacaine, 20cc injection of bupivacaine
- Medical subject headings
- Pain, Postoperative, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10cc injection of bupivacaineDrug
Also called Bupivacaine (Marcaine)
10cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist
20cc injection of bupivacaineDrug
Also called Bupivacaine (Marcaine)
20cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist
| Study group | Role | What they receive |
|---|---|---|
| 10cc Patients | Experimental | Intervention: Group 1 will receive 10cc of intra-operative intra-carpal tunnel anesthetic injection (bupivacaine/Marcaine). Postoperatively, patients will also be prescribed an opioid pain medication in congruence with current standard medical practice. Patients will be contacted at 24-hours, 48-hours, 72-hours, and at 2-week clinic follow-up by research staff and evaluated for pain levels through the LIKERT scale. Receives: Drug: 10cc injection of bupivacaine |
| 20cc Patients | Active comparator | Intervention: Group 2 will receive 20cc of intra-operative intra-carpal tunnel anesthetic injection (bupivacaine/Marcaine). Postoperatively, patients will also be prescribed an opioid pain medication in congruence with current standard medical practice. Patients will be contacted at 24-hours, 48-hours, 72-hours, and at 2-week clinic follow-up by research staff and evaluated for pain levels through the LIKERT scale. Receives: Drug: 20cc injection of bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Level in various stages of the post-operative period
The investigator will implement a survey using a LIKERT scale regarding post-operative pain levels.
Measured: Changes in pain scores at 24 hours, 48 hours, 72 hours, and 2 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start4 Oct 2018
- Primary completion4 Oct 2020
- Study completion4 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Schwartz-Fernandes, University of South Florida
- Investigators
- Francisco Schwartz-Fernandes, MD, Principal investigator, USF Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729375
- Sponsor's protocol ID
- Pro00033480
- Acronym
- CTR
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2018
- Last updated
- 18 Nov 2020
- 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 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release
- ClinicalTrials.gov ID
- NCT03729375
- Acronym / sponsor ID
- CTR / Pro00033480
- Conditions
- Pain, Postoperative, Carpal Tunnel Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 4 Oct 2020 (actual)
- Study completion
- 4 Oct 2020 (actual)
- First posted
- 2 Nov 2018 (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.
Carpal Tunnel Syndrome patients undergoing carpal tunnel release surgery performed by the PI will receive intra-operative injections of bupivacaine (Marcaine). Two groups of patients will be randomly selected and will receive either 10cc or 20cc of injection. Their post-operative pain scores and usage of post-operative pain medication will be recorded and analyzed.
Detailed description
This randomized control trial will be conducted at the USF Department of Orthopaedics at the USF Health Morsani Center after receiving approval from the USF Institutional Review Board. Patients will be evaluated Carpal Tunnel Syndrome and screened as candidates for Carpal Tunnel Release surgery, following the inclusion and exclusion criteria. The Medical Record Number (MRN) will be used to randomly assign into treatment interventions. Group 1 and group 2 will receive 10cc and 20cc of intra-operative intra-carpal tunnel anesthetic injection, respectively. Postoperatively, patients will be prescribed an opioid pain medication in congruence with current standard medical practice. Patients will be contacted at 24-hours, 48-hours, 72-hours, and at 2-week clinic follow-up by research staff and will be evaluated for pain levels through the LIKERT scale and pain management through use of prescribed and supplemental pain medications. All data will be analyzed through SPSS v25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10cc Patients | Experimental | Drug: 10cc injection of bupivacaineIntervention: Group 1 will receive 10cc of intra-operative intra-carpal tunnel anesthetic injection (bupivacaine/Marcaine). Postoperatively, patients will also be prescribed an opioid pain medication in congruence with current standard medical practice. Patients will be contacted at 24-hours, 48-hours, 72-hours, and at 2-week clinic follow-up by research staff and evaluated for pain levels through the LIKERT scale. |
| 20cc Patients | Active comparator | Drug: 20cc injection of bupivacaineIntervention: Group 2 will receive 20cc of intra-operative intra-carpal tunnel anesthetic injection (bupivacaine/Marcaine). Postoperatively, patients will also be prescribed an opioid pain medication in congruence with current standard medical practice. Patients will be contacted at 24-hours, 48-hours, 72-hours, and at 2-week clinic follow-up by research staff and evaluated for pain levels through the LIKERT scale. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient must be undergoing carpal tunnel release surgery performed by PI
- EMG or Ultrasound diagnosed carpal tunnel syndrome
Key exclusion criteria (1 listed)
- co-musculoskeletal injuries
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 |
|---|---|---|
| 10cc injection of bupivacaineAlso: Bupivacaine (Marcaine)10cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist | Drug | 10cc Patients |
| 20cc injection of bupivacaineAlso: Bupivacaine (Marcaine)20cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist | Drug | 20cc Patients |
Primary outcome
Change in Pain Level in various stages of the post-operative period
Time frame: Changes in pain scores at 24 hours, 48 hours, 72 hours, and 2 weeks post-operatively
The investigator will implement a survey using a LIKERT scale regarding post-operative pain levels.
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 18 Nov 2020.
- 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.
Francisco Schwartz-Fernandes, MD principal investigator
USF Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10cc injection of bupivacaine and 20cc injection of bupivacaine in people with Pain, Postoperative and Carpal Tunnel Syndrome, run by University of South Florida 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 2 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 18 Nov 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Change in Pain Level in various stages of the post-operative period (time frame: Changes in pain scores at 24 hours, 48 hours, 72 hours, and 2 weeks post-operatively). 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 18 Nov 2020.