PatientsVille.com LogoPatientsVille.com

Carpal Tunnel | Post-operative Analgesia in Elective, Soft-tissue Hand Surgery

Carpal Tunnel research study

What is the primary objective of this study?

The purpose of this research study is to find out which combination of pain medications following surgery work the best and result in the fewest side effects.

Who is eligible to participate?

Inclusion Criteria: - Age greater than or equal to 18 - Male or Female (non-pregnant) - Elective, soft tissue hand surgery indicated based on diagnosis made by either clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination of the two (carpal tunnel release, trigger finger release, first dorsal compartment release, ganglion cyst excision, second extensor compartment release) - Subjects are capable of giving informed consent Exclusion Criteria: - Allergy to study medication - Any pre-existing pain condition requiring analgesia - Fibromyalgia - Recent upper gastrointestinal bleeding - Coagulopathy (primary or medication-related) - Renal impairment - Liver disease - Pregnancy - Patients who consent to the study but require unexpected admission, including those requiring admission resulting from operative complications, will be excluded before randomization

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Carpal Tunnel

Ganglion Cyst

Trigger Finger

De Quervain Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Acetaminophen/HydrocodonePatients will be treated with acetaminophen 325 mg / Hydrocodone 5 mg

Drug:Acetaminophen/IbuprofenAcetaminophen 500 mg / Ibuprofen 400 mg

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Acetaminophen/Ibuprofen (AIGU) GroupAcetaminophen 325 mg and Hydrocodone 5 mg

Acetaminophen/Hydrocodone (AH) GroupAcetaminophen 500 mg and Ibuprofen 400 mg

Study Status

Enrolling by invitation

Start Date: February 2015

Completed Date: December 2021

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Efficacy comparison utilizing Visual Analog Scale (VAS), Pain Catastrophizing Scale, Likert Pain Score and Mean daily pain values

Secondary Outcome: Incidence of adverse effects

Study sponsors, principal investigator, and references

Principal Investigator: Alexander Payatakes, M.D.

Lead Sponsor: Alexander Payatakes, M.D.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02029235

Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.

Discuss Endocet