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

Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone

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.

Study Overview

• Status: Terminated
• Conditions: Trigger Finger; Carpal Tunnel; De Quervain Disease; Ganglion Cyst
• Intervention / Treatment: Drug: Acetaminophen/Ibuprofen; Drug: Acetaminophen/Hydrocodone

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Norco

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Comparison of Pain Relief	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	1 week postoperatively

Collaborators and Investigators

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

Publications and helpful links

General 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. doi: 10.1001/jama.297.3.249. No abstract available.
• 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, Choiniere M. Severity and impact of pain after day-surgery. Can J Anaesth. 1998 Apr;45(4):304-11. doi: 10.1007/BF03012019.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2015
• Primary Completion (Actual): November 17, 2017
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: January 3, 2014
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Adult; soft-tissue hand surgery
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Mucinoses; Tendinopathy; Tendon Entrapment; Ganglion Cysts; Trigger Finger Disorder; De Quervain Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Ibuprofen; Hydrocodone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: IRB - 00076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO