Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

NCT03111186 | Completed Phase 2 FDA Drug

• 1 other identifier: HS-15-00706
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Carpal Tunnel Syndrome; Dupuytren Contracture; Trigger Digit; Ganglion Cysts; De Quervain Disease

Keywords

oxycodone; ibuprofen; acetaminophen; soft-tissue hand surgery; carpal tunnel release; Dupuytren contracture release; Trigger digit release; Ganglion cyst removal; De Quervain's release

Outcome Measures

Primary Outcomes (1)

• change in VAS pain scale

  Visual Analog Score - pain scale, patient questionnaire

  baseline, daily - up to 1 week postoperative

Secondary Outcomes (2)

• change in Brief Pain Index

  baseline, daily - up to 1 week postoperative

• change in pain diary

  baseline, daily - up to 1 week postoperative

Study Arms (2)

Opiate group

ACTIVE COMPARATOR

Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain)

Drug: Oxycodone Hcl 5Mg

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)

Drug: Ibuprofen 400 mg; Drug: Acetaminophen 650 mg

Interventions

Oxycodone Hcl 5Mg DRUG

oxycodone HCl 5 mg up to six times daily as needed for pain

Also known as: oxycodone

Opiate group

Ibuprofen 400 mg DRUG

Ibuprofen 400 mg up to six times daily as needed for pain

Non-opiate group

Acetaminophen 650 mg DRUG

Acetaminophen 650 mg up to four times daily as needed for pain

Non-opiate group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (12)

• 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.

  PMID: 21593720 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.

  PMID: 25747738 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.

  PMID: 18443641 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.

  PMID: 22410178 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.

  PMID: 19628064 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.

  PMID: 11159230 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.

  PMID: 18308218 BACKGROUND

• Joris J. Efficacy of nonsteroidal antiinflammatory drugs in postoperative pain. Acta Anaesthesiol Belg. 1996;47(3):115-23.

  PMID: 8959196 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.

  PMID: 20142348 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.

  PMID: 11719741 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.

  PMID: 15277930 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.

  PMID: 20381981 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Dupuytren Contracture; Trigger Finger Disorder; Ganglion Cysts; De Quervain Disease

Interventions

Oxycodone; Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Tendon Entrapment; Tendinopathy; Cysts; Mucinoses

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Alidad Ghiassi, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Orthopaedic Surgery

Model Details: 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

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: April 24, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)