Clinical trial · Interventional
Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery
A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery
NCT03111186CI-TRIAL-00040872completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is about pain control and medication following outpatient soft-tissue hand surgery. We hope to learn if ibuprofen and acetaminophen will achieve similar pain relief and satisfaction when compared with oxycodone alone.
Conditions
Conditions (5)
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 Syndrome | — | UNRESOLVED | — |
| De Quervain Disease | — | UNRESOLVED | — |
| Dupuytren Contracture | Palmar Fibromatosis | ALIAS | 0.90 |
| Ganglion Cysts | — | UNRESOLVED | — |
| Trigger Digit | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen 650 mg | Drug | — | UNRESOLVED |
| Ibuprofen 400 mg | Drug | Ibuprofen | ALIAS |
| Oxycodone Hcl 5Mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Opiate group
- description
- Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain)
- interventionNames
- Drug: Oxycodone Hcl 5Mg
- type
- ACTIVE_COMPARATOR
- label
- Non-opiate group
- description
- Group receiving ibuprofen and acetaminophen (acetaminophen 650 mg up to four times daily and ibuprofen 400 mg up to six times daily as need for pain)
- interventionNames
- Drug: Ibuprofen 400 mg
- Drug: Acetaminophen 650 mg
Primary outcomes (1)
- measure
- change in VAS pain scale
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age greater than 18 years * scheduled to undergo elective outpatient soft tissue hand surgery for one of the following procedures: Carpal tunnel release, Dupuytren contracture release, trigger digit release, ganglion cyst removal, de Quervain's release. * primary language is English or Spanish Exclusion Criteria: * any pre-existing condition requiring preoperative opiate analgesia, eg chronic pain syndrome * allergy to acetaminophen, ibuprofen, or oxycodone * renal impairment or liver disease either documented based on history or when preoperative creatinine, BUN, or liver function tests are outside the normal range provided by the lab * peptic ulcer disease or any history of gastrointestinal bleeding * coagulopathy documented on history, review of systems, or based on preoperative lab testing where PT, PTT, or INR are outside the normal range provided by the lab * pregnancy based on positive beta-HCG test which is performed on the day of the surgical procedure as is standard protocol
References
Publications (12)
- BACKGROUNDColuzzi F, Bragazzi L, Di Bussolo E, Pizza G, Mattia C. Determinants of patient satisfaction in postoperative pain management following hand ambulatory day-surgery. Minerva Med. 2011 Jun;102(3):177-86. PMID 21593720
- BACKGROUNDMunns JJ, Awan HM. Trends in carpal tunnel surgery: an online survey of members of the American Society for Surgery of the Hand. J Hand Surg Am. 2015 Apr;40(4):767-71.e2. doi: 10.1016/j.jhsa.2014.12.046. Epub 2015 Mar 4. PMID 25747738
- BACKGROUNDManchikanti L, Singh A. Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids. Pain Physician. 2008 Mar;11(2 Suppl):S63-88. PMID 18443641
- 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
- BACKGROUNDNauta M, Landsmeer ML, Koren G. Codeine-acetaminophen versus nonsteroidal anti-inflammatory drugs in the treatment of post-abdominal surgery pain: a systematic review of randomized trials. Am J Surg. 2009 Aug;198(2):256-61. doi: 10.1016/j.amjsurg.2008.11.044. PMID 19628064
- BACKGROUNDRawal N, Allvin R, Amilon A, Ohlsson T, Hallen J. Postoperative analgesia at home after ambulatory hand surgery: a controlled comparison of tramadol, metamizol, and paracetamol. Anesth Analg. 2001 Feb;92(2):347-51. doi: 10.1097/00000539-200102000-00013. PMID 11159230
- BACKGROUNDMitchell A, van Zanten SV, Inglis K, Porter G. A randomized controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine after outpatient general surgery. J Am Coll Surg. 2008 Mar;206(3):472-9. doi: 10.1016/j.jamcollsurg.2007.09.006. Epub 2007 Nov 26.