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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03729375
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Francisco Schwartz-Fernandes, University of South Florida

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Carpal Tunnel Syndrome Drug: 10cc injection of bupivacaine Drug: 20cc injection of bupivacaine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : June 11, 2020
Estimated Study Completion Date : June 11, 2020


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 Name: 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 Name: Bupivacaine (Marcaine)




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729375


Contacts
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Contact: Andrew Sephien, BS 407-455-3694 sephien@health.usf.edu
Contact: Evan H Horowitz, MD 954-253-1652 evanhorowitz@health.usf.edu

Locations
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United States, Florida
University of South Florida Department of Orthopaedics Recruiting
Tampa, Florida, United States, 33612
Contact: Francisco Schwartz-Fernandes, MD       schwartzfernandes@health.usf.edu   
Sub-Investigator: Andrew Sephien, BS         
Sub-Investigator: Evan H Horowitz, MD         
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Francisco Schwartz-Fernandes, MD USF Orthopaedics
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Responsible Party: Francisco Schwartz-Fernandes, Assistant Professor, USF College of Medicine, Orthopaedics, University of South Florida
ClinicalTrials.gov Identifier: NCT03729375    
Other Study ID Numbers: Pro00033480
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pain, Postoperative
Postoperative Complications
Pathologic Processes
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
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents