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Post-operative Analgesia in Elective, Soft-tissue Hand Surgery

NCT ID: NCT02029235

Last Updated: 2018-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-10

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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This is a prospective, randomized, double-blind study comparing the efficacy of acetaminophen/hydrocodone (AH) to acetaminophen/ibuprofen (AIBU) in providing adequate post-operative pain relief in elective, soft tissue hand surgery patients.

Conditions

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Carpal Tunnel Ganglion Cyst Trigger Finger De Quervain Disease

Keywords

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Adult soft-tissue hand surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Acetaminophen/Ibuprofen (AIBU) Group

Acetaminophen 500 mg and Ibuprofen 400 mg

Group Type ACTIVE_COMPARATOR

Acetaminophen/Ibuprofen

Intervention Type DRUG

Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free

Acetaminophen/Hydrocodone (AH) Group

Acetaminophen 325 mg and Hydrocodone 5 mg

Group Type ACTIVE_COMPARATOR

Acetaminophen/Hydrocodone

Intervention Type DRUG

Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free

Interventions

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Acetaminophen/Ibuprofen

Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free

Intervention Type DRUG

Acetaminophen/Hydrocodone

Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free

Intervention Type DRUG

Other Intervention Names

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Acetaminophen/Tylenol Ibuprofen/Advil/Motrin Norco

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexander Payatakes, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Alexander Payatakes, M.D.

Principal Investigator / Sponsor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alexander Payatakes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22410178 (View on PubMed)

Kuehn 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.

Reference Type BACKGROUND
PMID: 17227967 (View on PubMed)

Centers 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.

Reference Type BACKGROUND
PMID: 20559200 (View on PubMed)

Mitchell 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.

Reference Type BACKGROUND
PMID: 22713999 (View on PubMed)

White 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.

Reference Type BACKGROUND
PMID: 21156974 (View on PubMed)

Beauregard 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.

Reference Type BACKGROUND
PMID: 9597202 (View on PubMed)

Dexter 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.

Reference Type BACKGROUND
PMID: 7717561 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB - 00076

Identifier Type: -

Identifier Source: org_study_id