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

Phase 1

Completed

• Conditions: Pain, Postoperative; Carpal Tunnel Syndrome
• Interventions: Drug: 10cc injection of bupivacaine; Drug: 20cc injection of bupivacaine

• Registration Number: NCT03729375
• Lead Sponsor: University of South Florida

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.

Study Timeline

• Study Start: 2018-10-04
• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Primary Completion: 2020-10-04
• Study Completion: 2020-10-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10cc Patients	10cc injection of bupivacaine	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.
20cc Patients	20cc injection of bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Change in Pain Level in various stages of the post-operative period	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.

Trial Locations

Locations (1)

University of South Florida Department of Orthopaedics; 🇺🇸 Tampa, Florida, United States