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

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ClinicalTrials.gov Identifier: NCT02029235

Recruitment Status : Terminated (Early termination due to slower than anticipated recruitment.)

First Posted : January 7, 2014

Results First Posted : December 13, 2018

Last Update Posted : December 13, 2018

Sponsor:

Information provided by (Responsible Party):

Alexander Payatakes, M.D., Milton S. Hershey Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Carpal Tunnel Ganglion Cyst Trigger Finger De Quervain Disease	Drug: Acetaminophen/Ibuprofen Drug: Acetaminophen/Hydrocodone	Phase 4

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	72 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone
Actual Study Start Date :	February 10, 2015
Actual Primary Completion Date :	November 17, 2017
Actual Study Completion Date :	June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Carpal tunnel syndrome

Drug Information available for: Acetaminophen Hydrocodone Hydrocodone bitartrate Hycodan Ibuprofen Ibuprofen sodium Ibuprofen lysine Midol

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Acetaminophen/Ibuprofen (AIBU) Group Acetaminophen 500 mg and Ibuprofen 400 mg	Drug: 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 Other Names: Acetaminophen/Tylenol Ibuprofen/Advil/Motrin
Active Comparator: Acetaminophen/Hydrocodone (AH) Group Acetaminophen 325 mg and Hydrocodone 5 mg	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 Other Name: Norco

Outcome Measures

Primary Outcome Measures :

Efficacy Comparison of Pain Intensity Level [ Time Frame: 1 week post-operatively ]
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.

Secondary Outcome Measures :

Efficacy Comparison of Pain Relief [ Time Frame: 1 week postoperatively ]
Subjects asked to fill out a patient diary recording their pain relief (on a Likert scale) one hour after taking study medication every 4 hours.

Daily average pain relief scores are reported as a score on a scale of 0-3, with higher score meaning better outcome.

The daily average pain relief scores were assessed daily for 1 week post-operatively, then compared using generalized linear mixed-effects models

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029235

Locations

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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Alexander Payatakes, M.D.

Investigators

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Principal Investigator:	Alexander Payatakes, M.D.	Milton S. Hershey Medical Center

Study Documents (Full-Text)

Documents provided by Alexander Payatakes, M.D., Milton S. Hershey Medical Center:

Study Protocol and Statistical Analysis Plan [PDF] November 10, 2014

More Information

Publications:

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.

Kuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007 Jan 17;297(3):249-51.

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.

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.

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.

Beauregard L, Pomp A, Choinière M. Severity and impact of pain after day-surgery. Can J Anaesth. 1998 Apr;45(4):304-11.

Dexter F, Chestnut DH. Analysis of statistical tests to compare visual analog scale measurements among groups. Anesthesiology. 1995 Apr;82(4):896-902.

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Responsible Party:	Alexander Payatakes, M.D., Principal Investigator / Sponsor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:	NCT02029235
Other Study ID Numbers:	IRB - 00076
First Posted:	January 7, 2014 Key Record Dates
Results First Posted:	December 13, 2018
Last Update Posted:	December 13, 2018
Last Verified:	December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Alexander Payatakes, M.D., Milton S. Hershey Medical Center:


Adult soft-tissue hand surgery

Additional relevant MeSH terms:

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Ganglion Cysts Trigger Finger Disorder De Quervain Disease Cysts Neoplasms Mucinoses Connective Tissue Diseases Tendon Entrapment Tendinopathy Muscular Diseases Musculoskeletal Diseases Acetaminophen Ibuprofen Acetaminophen, hydrocodone drug combination Hydrocodone	Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Central Nervous System Depressants

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