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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: 10cc injection of bupivacaine; Drug: 20cc injection of bupivacaine

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida Department of Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Bupivacaine (Marcaine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Francisco Schwartz-Fernandes, MD, USF Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Actual): October 4, 2020
• Study Completion (Actual): October 4, 2020

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Pain, Postoperative; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Pro00033480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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