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

NCT ID: NCT03729375

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2020-10-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Postoperative Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

10cc injection of bupivacaine

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

20cc injection of bupivacaine

Intervention Type DRUG

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

Interventions

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10cc injection of bupivacaine

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

Intervention Type DRUG

20cc injection of bupivacaine

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

Intervention Type DRUG

Other Intervention Names

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Bupivacaine (Marcaine) Bupivacaine (Marcaine)

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Francisco Schwartz-Fernandes

Assistant Professor, USF College of Medicine, Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Schwartz-Fernandes, MD

Role: PRINCIPAL_INVESTIGATOR

USF Orthopaedics

Locations

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University of South Florida Department of Orthopaedics

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00033480

Identifier Type: -

Identifier Source: org_study_id