Carpal TunnelPhase 4NCT02029235
Post-operative Analgesia in Elective, Soft-tissue Hand Surgery
A Phase 4 study testing Acetaminophen/Ibuprofen and Acetaminophen/Hydrocodone in people with Carpal Tunnel and Ganglion Cyst, run by Alexander Payatakes, M.D. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel, Ganglion Cyst, Trigger Finger
- What is being tested?
- Acetaminophen/Ibuprofen and Acetaminophen/Hydrocodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2015to 30 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergy to study medication
- Any pre-existing pain condition requiring analgesia
- Fibromyalgia
- Recent upper gastrointestinal bleeding
- Coagulopathy (primary or medication-related)
- Renal impairment
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
Read the 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.
- Conditions
- Carpal Tunnel, Ganglion Cyst, Trigger Finger, De Quervain Disease
- Being tested
- Acetaminophen/Ibuprofen, Acetaminophen/Hydrocodone
- Keywords
- Adult, soft-tissue hand surgery
- Medical subject headings
- Median Neuropathy, Ganglion Cysts, Trigger Finger Disorder, De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen/IbuprofenDrug
Also called Acetaminophen/Tylenol, Ibuprofen/Advil/Motrin
Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free
Acetaminophen/HydrocodoneDrug
Also called Norco
Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen/Ibuprofen (AIBU) Group | Active comparator | Acetaminophen 500 mg and Ibuprofen 400 mg Receives: Drug: Acetaminophen/Ibuprofen |
| Acetaminophen/Hydrocodone (AH) Group | Active comparator | Acetaminophen 325 mg and Hydrocodone 5 mg Receives: Drug: Acetaminophen/Hydrocodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week post-operatively
Secondary outcomes (1)
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
Measured: 1 week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study start10 Feb 2015
- Primary completion17 Nov 2017
- Study completion30 Jun 2018
Why it stopped: Early termination due to slower than anticipated recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Carpal TunnelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander Payatakes, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Payatakes, M.D., Milton S. Hershey Medical Center
- Investigators
- Alexander Payatakes, M.D., Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029235
- Sponsor's protocol ID
- IRB - 00076
- Status last verified
- Dec 2018
- First submitted
- 3 Jan 2014
- Last updated
- 13 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 22410178Kuehn 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.
PubMed 17227967Centers 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.
PubMed 20559200Mitchell 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.
PubMed 22713999White 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.
PubMed 21156974Beauregard 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.
PubMed 9597202Dexter 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.
PubMed 7717561
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone
- ClinicalTrials.gov ID
- NCT02029235
- Acronym / sponsor ID
- IRB - 00076
- Conditions
- Carpal Tunnel, Ganglion Cyst, Trigger Finger, De Quervain Disease
- Keywords
- Adult, soft-tissue hand surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to slower than anticipated recruitment.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Alexander Payatakes, M.D.University, hospital or other
- Study start
- 10 Feb 2015 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Posted 13 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen/Ibuprofen (AIBU) Group | Active comparator | Drug: Acetaminophen/IbuprofenAcetaminophen 500 mg and Ibuprofen 400 mg |
| Acetaminophen/Hydrocodone (AH) Group | Active comparator | Drug: Acetaminophen/HydrocodoneAcetaminophen 325 mg and Hydrocodone 5 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Allergy to study medication
- Any pre-existing pain condition requiring analgesia
- Fibromyalgia
- Recent upper gastrointestinal bleeding
- Coagulopathy (primary or medication-related)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen/IbuprofenAlso: Acetaminophen/Tylenol, Ibuprofen/Advil/MotrinPostoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free | Drug | Acetaminophen/Ibuprofen (AIBU) Group |
| Acetaminophen/HydrocodoneAlso: NorcoPostoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free | Drug | Acetaminophen/Hydrocodone (AH) Group |
Primary outcome
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.
1 secondary outcome
Efficacy Comparison of Pain Relief
Time frame: 1 week postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22410178Rodgers 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.
- Background: PubMed 17227967Kuehn 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.
- Background: PubMed 20559200Centers 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.
- Background: PubMed 22713999Mitchell 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.
- Background: PubMed 21156974White 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.
- Background: PubMed 9597202Beauregard 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.
- Background: PubMed 7717561Dexter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Payatakes, M.D. principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen/Ibuprofen and Acetaminophen/Hydrocodone in people with Carpal Tunnel and Ganglion Cyst, run by Alexander Payatakes, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Comparison of Pain Intensity Level (time frame: 1 week post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02029235, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.