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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03729375
Other study ID # Pro00033480
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 4, 2018
Est. completion date October 4, 2020

Study information

Verified date November 2020
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Their post-operative pain scores and usage of post-operative pain medication will be recorded and analyzed.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date October 4, 2020
Est. primary completion date October 4, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
10cc injection of bupivacaine
10cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist
20cc injection of bupivacaine
20cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist

Locations

Country Name City State
United States University of South Florida Department of Orthopaedics Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Changes in pain scores at 24 hours, 48 hours, 72 hours, and 2 weeks post-operatively
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