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

Primary Purpose

Pain, Postoperative, Carpal Tunnel Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
10cc injection of bupivacaine
20cc injection of bupivacaine
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Florida Department of Orthopaedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

10cc Patients

20cc Patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 29, 2018
Last Updated
November 16, 2020
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03729375
Brief Title
The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release
Acronym
CTR
Official Title
The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
October 4, 2020 (Actual)
Study Completion Date
October 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10cc Patients
Arm Type
Experimental
Arm Description
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.
Arm Title
20cc Patients
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
10cc injection of bupivacaine
Other Intervention Name(s)
Bupivacaine (Marcaine)
Intervention Description
10cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist
Intervention Type
Drug
Intervention Name(s)
20cc injection of bupivacaine
Other Intervention Name(s)
Bupivacaine (Marcaine)
Intervention Description
20cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist
Primary Outcome Measure Information:
Title
Change in Pain Level in various stages of the post-operative period
Description
The investigator will implement a survey using a LIKERT scale regarding post-operative pain levels.
Time Frame
Changes in pain scores at 24 hours, 48 hours, 72 hours, and 2 weeks post-operatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Schwartz-Fernandes, MD
Organizational Affiliation
USF Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida Department of Orthopaedics
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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