NCT02029235

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 10, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
6 months until next milestone

Results Posted

Study results publicly available

December 13, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

2.8 years

First QC Date

January 3, 2014

Results QC Date

October 22, 2018

Last Update Submit

December 12, 2018

Conditions

Carpal TunnelGanglion CystTrigger FingerDe Quervain Disease

Keywords

Adultsoft-tissue hand surgery

Outcome Measures

Primary Outcomes (1)

  • Efficacy Comparison of Pain Intensity Level

    Subjects asked to fill out a patient diary recording their pain intensity level (on 100mm Visual Analog Scale) prior to taking study medication every 4 hours. The daily average pain intensity levels are reported as a score on a scale of 0-100, with higher score meaning worse outcome. The daily average pain levels were assessed daily for 1 week post-operatively, then compared between the 2 groups using a two-group Student's t-test.

    1 week post-operatively

Secondary Outcomes (1)

  • Efficacy Comparison of Pain Relief

    1 week postoperatively

Study Arms (2)

Acetaminophen/Ibuprofen (AIBU) Group

ACTIVE COMPARATOR

Acetaminophen 500 mg and Ibuprofen 400 mg

Drug: Acetaminophen/Ibuprofen

Acetaminophen/Hydrocodone (AH) Group

ACTIVE COMPARATOR

Acetaminophen 325 mg and Hydrocodone 5 mg

Drug: Acetaminophen/Hydrocodone

Interventions

Acetaminophen/IbuprofenDRUG

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

Also known as: Acetaminophen/Tylenol, Ibuprofen/Advil/Motrin
Acetaminophen/Ibuprofen (AIBU) Group
Acetaminophen/HydrocodoneDRUG

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

Also known as: Norco
Acetaminophen/Hydrocodone (AH) Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (7)

  • 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: 22410178BACKGROUND

  • 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.

    PMID: 17227967BACKGROUND

  • 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.

    PMID: 20559200BACKGROUND

  • 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.

    PMID: 22713999BACKGROUND

  • 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.

    PMID: 21156974BACKGROUND

  • 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.

    PMID: 9597202BACKGROUND

  • 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.

    PMID: 7717561BACKGROUND

MeSH Terms

Conditions

Median NeuropathyGanglion CystsTrigger Finger DisorderDe Quervain Disease

Interventions

AcetaminophenIbuprofenoxycodone-acetaminophen

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesCystsNeoplasmsMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesTendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Limitations and Caveats

Early termination due to slower than anticipated recruitment.

Results Point of Contact

Title
Alexander Payatakes, MD
Organization
Penn State Health Milton S. Hershey Medical Center
apayatakes@pennstatehealth.psu.edu
717-531-4805

Study Officials

  • Alexander Payatakes, M.D.

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator / Sponsor

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 7, 2014

Study Start

February 10, 2015

Primary Completion

November 17, 2017

Study Completion

June 30, 2018

Last Updated

December 13, 2018

Results First Posted

December 13, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)