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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of South Florida Department of Orthopaedics

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10cc injection of bupivacaine

Drug

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

Other names: Bupivacaine (Marcaine)

20cc injection of bupivacaine

Drug

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

Other names: Bupivacaine (Marcaine)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Acronym: CTR

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Nov 2, 2018
Registry last updated: Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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