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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.
Opiate analgesics remain the most popular option following outpatient hand surgery despite growing evidence that non-opiate analgesics may provide equivalent pain relief with fewer adverse effects and greater overall satisfaction. The purpose of this randomized trial is to compare the efficacy, side effect profiles and satisfaction associated with Ibuprofen plus Acetaminophen versus Oxycodone alone following outpatient hand surgery. No previous studies have compared the use of opiate analgesics with acetaminophen/ibuprofen following outpatient hand surgery. Patients will be randomized to receive either oxycodone alone or acetaminophen and ibuprofen following outpatient soft tissue hand surgery. Patients will be randomized to receive one of the two aforementioned pain regimens. Patients will be given a booklet in which to record pain level by visual analog scale (VAS), satisfaction with pain control, brief pain inventory and any side effects. Patients will be seen in clinic 1 week after surgery to review symptoms. Patients may also be contacted by phone to review daily log of symptoms. Patients will be seen in clinic 1 week after surgery per standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opiate group | Active Comparator | Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain) |
|
| Non-opiate group | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone Hcl 5Mg | Drug | oxycodone HCl 5 mg up to six times daily as needed for pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in VAS pain scale | Visual Analog Score - pain scale, patient questionnaire | baseline, daily - up to 1 week postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| change in Brief Pain Index | Brief Pain Index - pain scale, patient questionnaire | baseline, daily - up to 1 week postoperative |
| change in pain diary | Pain Diary - pain scale, patient questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alidad Ghiassi, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck School of Medicine of the University of Southern California | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21593720 | Background | Coluzzi 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. | |
| 25747738 | Background | Munns 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| HS-15-00706 | Study Protocol | View IPD |
Data will be shared as required with the USC Health Sciences Institutional Review Board. Participant data will be coded with coding identifiers kept separately by research personnel only and destroyed upon completion of the study.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 23, 2024 | Feb 13, 2024 | 4 |
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D004387 | Dupuytren Contracture |
| D052582 | Trigger Finger Disorder |
| D045888 | Ganglion Cysts |
| D053684 | De Quervain Disease |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Patients of either sex, greater than 18 years of age, 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, whose primary language is English or Spanish
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| Ibuprofen 400 mg | Drug | Ibuprofen 400 mg up to six times daily as needed for pain |
|
| Acetaminophen 650 mg | Drug | Acetaminophen 650 mg up to four times daily as needed for pain |
|
| baseline, daily - up to 1 week postoperative |
| 18443641 | Background | Manchikanti 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. |
| 22410178 | Background | 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. |
| 19628064 | Background | Nauta 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. |
| 11159230 | Background | Rawal 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. |
| 18308218 | Background | Mitchell 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. |
| 8959196 | Background | Joris J. Efficacy of nonsteroidal antiinflammatory drugs in postoperative pain. Acta Anaesthesiol Belg. 1996;47(3):115-23. |
| 20142348 | Background | Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8. |
| 11719741 | Background | Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863. |
| 15277930 | Background | McCartney CJ, Brull R, Chan VW, Katz J, Abbas S, Graham B, Nova H, Rawson R, Anastakis DJ, von Schroeder H. Early but no long-term benefit of regional compared with general anesthesia for ambulatory hand surgery. Anesthesiology. 2004 Aug;101(2):461-7. doi: 10.1097/00000542-200408000-00028. |
| 20381981 | Background | Vranceanu AM, Jupiter JB, Mudgal CS, Ring D. Predictors of pain intensity and disability after minor hand surgery. J Hand Surg Am. 2010 Jun;35(6):956-60. doi: 10.1016/j.jhsa.2010.02.001. Epub 2010 Apr 9. |
| HS-15-00706 | Informed Consent Form | View IPD |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D003560 | Cysts |
| D017520 | Mucinoses |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |