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Post-operative Analgesia in Elective, Soft-tissue Hand Surgery

A

Alexander Payatakes, M.D.

Status and phase

Terminated
Phase 4

Conditions

De Quervain Disease
Ganglion Cyst
Trigger Finger
Carpal Tunnel

Treatments

Drug: Acetaminophen/Hydrocodone
Drug: Acetaminophen/Ibuprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT02029235
IRB - 00076

Details and patient eligibility

About

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.

Full description

This is a prospective, randomized, double-blind study comparing the efficacy of acetaminophen/hydrocodone (AH) to acetaminophen/ibuprofen (AIBU) in providing adequate post-operative pain relief in elective, soft tissue hand surgery patients.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 2 patient groups

Acetaminophen/Ibuprofen (AIBU) Group
Active Comparator group
Description:
Acetaminophen 500 mg and Ibuprofen 400 mg
Treatment:
Drug: Acetaminophen/Ibuprofen
Acetaminophen/Hydrocodone (AH) Group
Active Comparator group
Description:
Acetaminophen 325 mg and Hydrocodone 5 mg
Treatment:
Drug: Acetaminophen/Hydrocodone

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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