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The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release

The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03729375
Acronym
CTR
Enrollment
52
Registered
2018-11-02
Start date
2018-10-04
Completion date
2020-10-04
Last updated
2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Pain, Postoperative

Brief 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.

Interventions

DRUG10cc injection of bupivacaine

10cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist

DRUG20cc injection of bupivacaine

20cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist

Sponsors

University of South Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patient must be undergoing carpal tunnel release surgery performed by PI * EMG or Ultrasound diagnosed carpal tunnel syndrome

Exclusion criteria

* co-musculoskeletal injuries

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Level in various stages of the post-operative periodChanges in pain scores at 24 hours, 48 hours, 72 hours, and 2 weeks post-operativelyThe investigator will implement a survey using a LIKERT scale regarding post-operative pain levels.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026