Clinical trial · Interventional
Post-operative Analgesia in Elective, Soft-tissue Hand Surgery
Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone
NCT02029235CI-TRIAL-00036124terminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early termination due to slower than anticipated recruitment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carpal Tunnel | — | UNRESOLVED | — |
| De Quervain Disease | — | UNRESOLVED | — |
| Ganglion Cyst | — | UNRESOLVED | — |
| Trigger Finger | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen/Hydrocodone | Drug | — | UNRESOLVED |
| Acetaminophen/Ibuprofen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Acetaminophen/Ibuprofen (AIBU) Group
- description
- Acetaminophen 500 mg and Ibuprofen 400 mg
- interventionNames
- Drug: Acetaminophen/Ibuprofen
- type
- ACTIVE_COMPARATOR
- label
- Acetaminophen/Hydrocodone (AH) Group
- description
- Acetaminophen 325 mg and Hydrocodone 5 mg
- interventionNames
- Drug: Acetaminophen/Hydrocodone
Primary outcomes (1)
- measure
- Efficacy Comparison of Pain Intensity Level
- timeFrame
- 1 week post-operatively
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDRodgers 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. PMID 22410178
- BACKGROUNDKuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007 Jan 17;297(3):249-51. doi: 10.1001/jama.297.3.249. No abstract available. PMID 17227967
- BACKGROUNDCenters for Disease Control and Prevention (CDC). Emergency department visits involving nonmedical use of selected prescription drugs - United States, 2004-2008. MMWR Morb Mortal Wkly Rep. 2010 Jun 18;59(23):705-9. PMID 20559200
- BACKGROUNDMitchell A, McCrea P, Inglis K, Porter G. A randomized, controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine (Tylenol 3) after outpatient breast surgery. Ann Surg Oncol. 2012 Nov;19(12):3792-800. doi: 10.1245/s10434-012-2447-7. Epub 2012 Jun 20. PMID 22713999
- BACKGROUNDWhite PF, Tang J, Wender RH, Zhao M, Time M, Zaentz A, Yumul R, Sloninsky A, Naruse R, Kariger R, Webb T, Fermelia DE, Tsushima GK. The effects of oral ibuprofen and celecoxib in preventing pain, improving recovery outcomes and patient satisfaction after ambulatory surgery. Anesth Analg. 2011 Feb;112(2):323-9. doi: 10.1213/ANE.0b013e3182025a8a. Epub 2010 Dec 14. PMID 21156974
- BACKGROUNDBeauregard L, Pomp A, Choiniere M. Severity and impact of pain after day-surgery. Can J Anaesth. 1998 Apr;45(4):304-11. doi: 10.1007/BF03012019. PMID 9597202
- BACKGROUNDDexter F, Chestnut DH. Analysis of statistical tests to compare visual analog scale measurements among groups. Anesthesiology. 1995 Apr;82(4):896-902. doi: 10.1097/00000542-199504000-00012. PMID 7717561