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
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Ganglion Cyst Trigger Finger De Quervain Disease||Drug: Acetaminophen/Ibuprofen Drug: Acetaminophen/Hydrocodone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: Acetaminophen/Ibuprofen (AIBU) Group
Acetaminophen 500 mg and Ibuprofen 400 mg
Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free
Active Comparator: Acetaminophen/Hydrocodone (AH) Group
Acetaminophen 325 mg and Hydrocodone 5 mg
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
- 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.
- 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
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
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Alexander Payatakes, M.D.||Milton S. Hershey Medical Center|