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

Trigger Finger Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02029235
• Other study ID #: IRB - 00076
• Status: Terminated
• Phase: Phase 4
• Start date: February 10, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: December 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: June 30, 2018
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel
• Carpal Tunnel Syndrome
• De Quervain Disease
• Ganglion Cyst
• Ganglion Cysts
• Trigger Finger
• Trigger Finger Disorder

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Alexander Payatakes, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

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. — View Citation

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

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

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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