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Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

Primary Purpose

Carpal Tunnel Syndrome, Dupuytren Contracture, Trigger Digit

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Oxycodone Hcl 5Mg

Ibuprofen 400 mg

Acetaminophen 650 mg

About this trial

This is an interventional supportive care trial for Carpal Tunnel Syndrome focused on measuring oxycodone, ibuprofen, acetaminophen, soft-tissue hand surgery, carpal tunnel release, Dupuytren contracture release, Trigger digit release, Ganglion cyst removal, De Quervain's release

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Keck School of Medicine of the University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Opiate group

Non-opiate group

Arm Description

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

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)

Outcomes

Primary Outcome Measures

change in VAS pain scale

Visual Analog Score - pain scale, patient questionnaire

Secondary Outcome Measures

change in Brief Pain Index

Brief Pain Index - pain scale, patient questionnaire

change in pain diary

Pain Diary - pain scale, patient questionnaire

Full Information

NCT ID

NCT03111186

First Posted

April 6, 2017

Last Updated

September 24, 2019

Sponsor

University of Southern California

1. Study Identification

Unique Protocol Identification Number

NCT03111186

Brief Title

Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

Official Title

A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

April 24, 2017 (Actual)

Primary Completion Date

May 1, 2019 (Actual)

Study Completion Date

May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Opiate group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Non-opiate group

Arm Type

Active Comparator

Arm 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)

Intervention Type

Drug

Intervention Name(s)

Oxycodone Hcl 5Mg

Other Intervention Name(s)

oxycodone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ibuprofen 400 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Acetaminophen 650 mg

Intervention Description

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

Primary Outcome Measure Information:

Title

change in VAS pain scale

Description

Visual Analog Score - pain scale, patient questionnaire

Time Frame

baseline, daily - up to 1 week postoperative

Secondary Outcome Measure Information:

Title

change in Brief Pain Index

Description

Brief Pain Index - pain scale, patient questionnaire

Time Frame

baseline, daily - up to 1 week postoperative

Title

change in pain diary

Description

Pain Diary - pain scale, patient questionnaire

Time Frame

baseline, daily - up to 1 week postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alidad Ghiassi, MD

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

Keck School of Medicine of the University of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

21593720

Citation

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.

Results Reference

background

PubMed Identifier

25747738

Citation

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.

Results Reference

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PubMed Identifier

18443641

Citation

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.

Results Reference

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PubMed Identifier

22410178

Citation

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.

Results Reference

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PubMed Identifier

19628064

Citation

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.

Results Reference

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PubMed Identifier

11159230

Citation

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.

Results Reference

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PubMed Identifier

18308218

Citation

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.

Results Reference

background

PubMed Identifier

8959196

Citation

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

Results Reference

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PubMed Identifier

20142348

Citation

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.

Results Reference

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PubMed Identifier

11719741

Citation

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.

Results Reference

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PubMed Identifier

15277930

Citation

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. Erratum In: Anesthesiology. 2004 Oct;101(4):1057.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

background

Available IPD and Supporting Information:

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

http://istar.usc.edu

Available IPD/Information Identifier

HS-15-00706

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

http://istar.usc.edu

Available IPD/Information Identifier

HS-15-00706

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Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

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