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

NCT03729375 | Completed Phase 1 FDA Drug

• 1 other identifier: Pro00033480
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

10cc Patients

EXPERIMENTAL

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

20cc Patients

ACTIVE COMPARATOR

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

Interventions

10cc injection of bupivacaine DRUG

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

Also known as: Bupivacaine (Marcaine)

10cc Patients

20cc injection of bupivacaine DRUG

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

Also known as: Bupivacaine (Marcaine)

20cc Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• co-musculoskeletal injuries

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida Department of Orthopaedics

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Carpal Tunnel Syndrome

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Francisco Schwartz-Fernandes, MD

  USF Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, USF College of Medicine, Orthopaedics

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 2, 2018
• Study Start: October 4, 2018
• Primary Completion: October 4, 2020
• Study Completion: October 4, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)