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

• ClinicalTrials.gov Identifier: NCT03729375
• Recruitment Status: Completed
• First Posted: November 2, 2018
• Last Update Posted: November 18, 2020
• Sponsor: University of South Florida
• Information provided by (Responsible Party): Francisco Schwartz-Fernandes, University of South Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative; Carpal Tunnel Syndrome	Drug: 10cc injection of bupivacaine; Drug: 20cc injection of bupivacaine	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release
• Actual Study Start Date: October 4, 2018
• Actual Primary Completion Date: October 4, 2020
• Actual Study Completion Date: October 4, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 10cc Patients; 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.	Drug: 10cc injection of bupivacaine; 10cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist; Other Name: Bupivacaine (Marcaine)
Active Comparator: 20cc Patients; 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.	Drug: 20cc injection of bupivacaine; 20cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist; Other Name: Bupivacaine (Marcaine)

Outcome Measures

Primary Outcome Measures :

1. Change in Pain Level in various stages of the post-operative period [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

University of South Florida Department of Orthopaedics

Tampa, Florida, United States, 33612

Sponsors and Collaborators

University of South Florida

Investigators

• Principal Investigator: Francisco Schwartz-Fernandes, MD; USF Orthopaedics

More Information

• Responsible Party: Francisco Schwartz-Fernandes, Assistant Professor, USF College of Medicine, Orthopaedics, University of South Florida
• ClinicalTrials.gov Identifier: NCT03729375
• Other Study ID Numbers: Pro00033480
• First Posted: November 2, 2018
• Last Update Posted: November 18, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Carpal Tunnel Syndrome; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents