Trials / Completed
CompletedNCT03729375
The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- University of South Florida · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 10cc injection of bupivacaine | 10cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist |
| DRUG | 20cc injection of bupivacaine | 20cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist |
Timeline
- Start date
- 2018-10-04
- Primary completion
- 2020-10-04
- Completion
- 2020-10-04
- First posted
- 2018-11-02
- Last updated
- 2020-11-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03729375. Inclusion in this directory is not an endorsement.