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

Pain, Postoperative Clinical Trial

— CTR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03729375
• Other study ID #: Pro00033480
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Pain, Postoperative

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