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

University of South Florida

Status and phase: Completed; Phase 1

Conditions: Carpal Tunnel Syndrome; Pain, Postoperative

Treatments: Drug: 20cc injection of bupivacaine; Drug: 10cc injection of bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03729375

Pro00033480

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

10cc Patients

Experimental group

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.

Treatment:

Drug: 10cc injection of bupivacaine

20cc Patients

Active Comparator group

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.

Treatment:

Drug: 20cc injection of bupivacaine