Back to results

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

Primary Purpose

Carpal Tunnel, Ganglion Cyst, Trigger Finger

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Acetaminophen/Ibuprofen

Acetaminophen/Hydrocodone

About this trial

This is an interventional treatment trial for Carpal Tunnel focused on measuring Adult, soft-tissue hand surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Acetaminophen/Ibuprofen (AIBU) Group

Acetaminophen/Hydrocodone (AH) Group

Arm Description

Acetaminophen 500 mg and Ibuprofen 400 mg

Acetaminophen 325 mg and Hydrocodone 5 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02029235

First Posted

January 3, 2014

Last Updated

December 12, 2018

Sponsor

Alexander Payatakes, M.D.

1. Study Identification

Unique Protocol Identification Number

NCT02029235

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Terminated

Why Stopped

Early termination due to slower than anticipated recruitment.

Study Start Date

February 10, 2015 (Actual)

Primary Completion Date

November 17, 2017 (Actual)

Study Completion Date

June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Alexander Payatakes, M.D.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel, Ganglion Cyst, Trigger Finger, De Quervain Disease

Keywords

Adult, soft-tissue hand surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acetaminophen/Ibuprofen (AIBU) Group

Arm Type

Active Comparator

Arm Description

Acetaminophen 500 mg and Ibuprofen 400 mg

Arm Title

Acetaminophen/Hydrocodone (AH) Group

Arm Type

Active Comparator

Arm Description

Acetaminophen 325 mg and Hydrocodone 5 mg

Intervention Type

Drug

Intervention Name(s)

Acetaminophen/Ibuprofen

Other Intervention Name(s)

Acetaminophen/Tylenol, Ibuprofen/Advil/Motrin

Intervention Description

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

Intervention Name(s)

Acetaminophen/Hydrocodone

Other Intervention Name(s)

Norco

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy Comparison of Pain Intensity Level

Description

Time Frame

1 week post-operatively

Secondary Outcome Measure Information:

Title

Efficacy Comparison of Pain Relief

Description

Time Frame

1 week postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Payatakes, M.D.

Organizational Affiliation

Milton S. Hershey Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22410178

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.

Results Reference

background

PubMed Identifier

17227967

Citation

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.

Results Reference

background

PubMed Identifier

20559200

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.

Results Reference

background

PubMed Identifier

22713999

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.

Results Reference

background

PubMed Identifier

21156974

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.

Results Reference

background

PubMed Identifier

9597202

Citation

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.

Results Reference

background

PubMed Identifier

7717561

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs