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Early termination due to slower than anticipated recruitment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen/Ibuprofen (AIBU) Group | Active Comparator | Acetaminophen 500 mg and Ibuprofen 400 mg |
|
| Acetaminophen/Hydrocodone (AH) Group | Active Comparator | Acetaminophen 325 mg and Hydrocodone 5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen/Ibuprofen | Drug | Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Payatakes, M.D. | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22410178 | Background | 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. | |
| 17227967 | Background | 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. |
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Seven patients withdrew or were excluded prior to randomization due to cancellation of surgery (3), refusal to participate (3), and a newly diagnosed gastrointestinal ulcer (exclusion criterion) prior to surgery (1).
Participants were recruited during clinic visits to discuss elective, soft tissue hand surgery at a single academic medical center between February 2015 and October 2017. The first participant was enrolled in February 2015, and the last participant was enrolled in October 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen/Ibuprofen (AIBU) Group | Postoperatively, subjects were given: Acetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free. |
| FG001 | Acetaminophen/Hydrocodone (AH) Group | Postoperatively, subjects were given: Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects randomized into study groups and completing protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen/Ibuprofen (AIBU) Group | Postoperatively, subjects were given: Acetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free. |
| BG001 | Acetaminophen/Hydrocodone (AH) Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | score on a scale (0-100, higher = worse) | 1 week post-operatively |
|
2 weeks
Definition consistent with those listed on clinicaltrials.gov website.
Adverse event collection occurred at postop day 7 phone call, as well as first follow-up clinic-visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetaminophen/Ibuprofen (AIBU) Group | Acetaminophen 500 mg and Ibuprofen 400 mg 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders | Systematic Assessment |
Early termination due to slower than anticipated recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Payatakes, MD | Penn State Health Milton S. Hershey Medical Center | 717-531-4805 | apayatakes@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2014 | Oct 21, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D045888 | Ganglion Cysts |
| D052582 | Trigger Finger Disorder |
| D053684 | De Quervain Disease |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Acetaminophen/Hydrocodone | Drug | Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free |
|
|
| 1 week postoperatively |
| 20559200 | Background | 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. |
| 22713999 | Background | 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. |
| 21156974 | Background | 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. |
| 9597202 | Background | 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. |
| 7717561 | Background | 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. |
Postoperatively, subjects were given:
Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-0) objectifies degree of depression severity. It provides a total score on a scale of 0 - 27, with higher being worse (i.e. more severe depression). | Mean | Full Range | units on a scale (total score) |
|
Postoperatively, subjects were given: Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free. |
|
|
|
| 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 | Posted | Mean | Full Range | score on a scale (0-3, higher = better) | 1 week postoperatively |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 1 |
| 34 |
| EG001 | Acetaminophen/Hydrocodone (AH) Group | Acetaminophen 325 mg and Hydrocodone 5 mg 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 | 0 | 31 | 0 | 31 | 7 | 31 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Itchiness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D003560 | Cysts |
| D009369 | Neoplasms |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| Daily average pain relief on PostOp Day 3 |
|
| Daily average pain relief on PostOp Day 4 |
|
| Daily average pain relief on PostOp Day 5 |
|
| Daily average pain relief on PostOp Day 6 |
|
| Daily average pain relief on PostOp Day 7 |
|