Perioperative PainPhase 3NCT04813991
Pain Control Without Opioids
A Phase 3 study testing Ibuprofen 600 mg and OxyCODONE 5 Mg Oral Capsule in people with Perioperative Pain, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
Adequate outpatient pain control after uncomplicated laparoscopic appendectomy or cholecystectomy can be achieved with minimal breakthrough drugs when used in combination with around the clock non-opioid medications. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Perioperative Pain
- What is being tested?
- Ibuprofen 600 mg and OxyCODONE 5 Mg Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 1 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-90
- English or Spanish speaking
- Undergoing routine laparoscopic appendectomy or cholecystectomy
- Able to provide Informed Consent
Who cannot join
- Current use of methadone
- Opioid use within 30 days prior to hospitalization
- Actively taking anti-inflammatory medications
- History of Adverse Reactions to Study Medications
- Pregnancy
- Currently Breastfeeding
Show all 14Show fewer
- Ongoing treatment for Peptic Ulcer Disease
- Hepatitis, cirrhosis, severe liver dysfunction (elevated MELD score or LFT's > twice the upper limit of normal.)
- Renal dysfunction with a creatinine more than 25% above age normal values.
- Taking any medicine that might interact with one of the study medications such as SSRI's or Tricyclics, anti-psychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort
- The subject will be withdrawn from the study prior to any randomization if the following occurs:
- Conversion from laparoscopic to open procedure
- Subject does not undergo any operation;
- Subject has a complicated hospital course requiring prolonged hospitalization; subject experiences post-operative complications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Achieving Peri-Operative Pain Control Without Opioids
Adequate outpatient pain control after uncomplicated laparoscopic appendectomy or cholecystectomy can be achieved with minimal breakthrough drugs when used in combination with around the clock non-opioid medications.
Read the detailed description
Death from opioid overdose is now considered a national emergency. Prescribing of narcotics by physicians, particularly in the perioperative period, remains a significant contributor to opioid addiction. There is a critical need to identify post-operative pain control alternatives that eliminate narcotic usage. Without such information, clinicians will continue to rely on opioids to manage their patients' pain. Prior work supports the notion that there is little difference between the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) and that of opioid analgesics in controlling pain following surgical procedures. Recent clinical trials have concluded that a combination of centrally and peripherally acting analgesics improves patients' satisfaction and pain control. Clinical investigators have focused upon limiting opioid use rather than on eliminating the administration of narcotics. not surprisingly, there are no established evidenced-based guidelines for postoperative outpatient non-opioid pain control. The majority of U.S. surgeons continue to rely on opioids as the sole outpatient pain regimen, as suggested by a number of current guidelines.
Our observation is that adequate outpatient pain control after uncomplicated laparoscopic appendectomy or cholecystectomy can be achieved with minimal breakthrough drugs when used in combination with around the clock non-opioid medications.
The amount of opioids prescribed at discharge after laparoscopic appendectomies and cholecystectomies is quite variable. An average prescription is for 200-350 Oral Morphine Equivalents (OME) or 26-46 tabs of 5mg oxycodone with the lowest amount reported of 150 OME (20 tabs of 5mg oxy). One of the most conservative guidelines, the Michigan Surgical Quality Collaborative, recommends prescription of 75 OME after laparoscopic cholecystectomy
AIMS AND OBJECTIVES.
- Characterize the need for breakthrough pain medication in a cohort of post-operative subjects treated utilizing a 3-day pain regimen consisting of ibuprofen and acetaminophen for postoperative outpatient pain control without the use of opioids.
- Test the non-inferiority of a regimen consisting of ibuprofen when prescribed on as needed basis in controlling breakthrough pain compared with a regimen using oxycodone.
HYPOTHESIS
We predict that a non-opioid regimen can safely control post-operative pain as effectively as management protocols which include narcotics.
At the completion of the proposed research, our expected outcomes are to demonstrate that the ibuprofen/acetaminophen regimen provides adequate pain relief in patients who undergo uncomplicated laparoscopic cholecystectomy and appendectomy.
We also expect to have demonstrated that when breakthrough pain occurs, non-narcotic medications are as effective as opioids. These findings will be relevant to some 10 million surgeries per year in the U.S. where the patients may never need opioid exposure.
STUDY DESIGN/METHOLOGY
In this single-center, randomized, double-blind intervention trial, adult subjects will be enrolled after routine uncomplicated laparoscopic appendectomy or cholecystectomy for the management of outpatient pain. All participants will provide written informed consent.
All subjects will receive two oral analgesic medications (ibuprofen 600mg and acetaminophen 500mg) three times per day with meals, to consume for three days following discharge from the hospital. For breakthrough pain, with a double-blind approach with opaque capsules for the medications, subjects will be randomized to receive five packages of two pills containing either ibuprofen 600mg (Arm 1) or oxycodone 5mg(Arm 2). They will be instructed to consume breakthrough medications no more than twice per day.
The subjects will maintain a pain log and will record their pain intensity prior to meals each day, and also the maximum pain intensity for the given day, using a verbal pain Numerical Rating Scale (NRS) that ranges from 0 to 10.
A research team member will contact each subject daily by phone for seven days and confirm the subject is consuming their medications and collect information regarding pain intensity.
Subjects will be asked the following questions:
- To rate their pain on a scale of 0 to 10 daily, average and maximum.
- To report the # of breakthrough pain medication pills taken that day and how many total remain
If the subject reports a pain score of 8 or greater after taking the both breakthrough medications during a 24 hour period, they will be considered a study failure. Patient will be told to contact their surgeon for follow up. The research coordinator will follow up these subjects to confirm they have spoken to their treating physician.
- Conditions
- Perioperative Pain
- Being tested
- Ibuprofen 600 mg, OxyCODONE 5 Mg Oral Capsule
- Keywords
- Opioid Analgesic, Ibuprofen, Pain control, Acetaminophen, Laparoscopic Cholescystectomy, Laparoscopic Appendectomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 600 mgDrug
Ibuprofen 600 mg for breakthrough pain.
OxyCODONE 5 Mg Oral CapsuleDrug
OxyCODONE 5 Mg Oral Capsule for breakthrough pain.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Ibuprofen Breakthrough | Experimental | 600 mg Ibuprofen for breakthrough pain. Receives: Drug: Ibuprofen 600 mg |
| Arm 2 - Oxycodone Breakthrough | Active comparator | 5 mg of Oxycodone for breakthrough pain. Receives: Drug: OxyCODONE 5 Mg Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Breakthrough Pain
The need for breakthrough pain medication will be characterized by the estimate of the incidence density for starting breakthrough medication. We will examine potential predictors of the need for breakthrough medication using an actuarial approach
Measured: 7 Days
Secondary outcomes (1)
Time-weighted average daily pain score over first three days post-discharge.
The subjects will maintain a pain log and will record their pain intensity prior to meals each day, and also the maximum pain intensity for the given day, using a verbal pain Numerical Rating Scale (NRS) that ranges from 0 to 10. We will use a general linear model (GLM) approach comparing time-weighted average pain scores over 72-hours as the dependent variable.
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start15 Mar 2022 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Why it stopped: Enrollment was never initiated and the PI is leaving the institution so the study is closing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Perioperative PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double-Blind Intervention Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813991
- Sponsor's protocol ID
- PRO2020-0546
- Status last verified
- Sep 2022
- First submitted
- 22 Mar 2021
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gostin LO, Hodge JG Jr, Noe SA. Reframing the Opioid Epidemic as a National Emergency. JAMA. 2017 Oct 24;318(16):1539-1540. doi: 10.1001/jama.2017.13358. No abstract available.
PubMed 28832871Tan WH, Yu J, Feaman S, McAllister JM, Kahan LG, Quasebarth MA, Blatnik JA, Eagon JC, Awad MM, Brunt LM. Opioid Medication Use in the Surgical Patient: An Assessment of Prescribing Patterns and Use. J Am Coll Surg. 2018 Aug;227(2):203-211. doi: 10.1016/j.jamcollsurg.2018.04.032. Epub 2018 May 7.
PubMed 29746919Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. Lancet. 2019 Apr 13;393(10180):1547-1557. doi: 10.1016/S0140-6736(19)30428-3.
PubMed 30983590White PF, Joshi GP, Carpenter RL, Fragen RJ. A comparison of oral ketorolac and hydrocodone-acetaminophen for analgesia after ambulatory surgery: arthroscopy versus laparoscopic tubal ligation. Anesth Analg. 1997 Jul;85(1):37-43. doi: 10.1097/00000539-199707000-00007.
PubMed 9212119Singla N, Pong A, Newman K; MD-10 Study Group. Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of pain after abdominal or pelvic surgery in women: a randomized, double-blind, placebo- and active-controlled parallel-group study. Clin Ther. 2005 Jan;27(1):45-57. doi: 10.1016/j.clinthera.2005.01.010.
PubMed 15763605Mitchell A, van Zanten SV, Inglis K, Porter G. A randomized controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine after outpatient general surgery. J Am Coll Surg. 2008 Mar;206(3):472-9. doi: 10.1016/j.jamcollsurg.2007.09.006. Epub 2007 Nov 26.
PubMed 18308218Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.
PubMed 20642488Ahiskalioglu EO, Ahiskalioglu A, Aydin P, Yayik AM, Temiz A. Effects of single-dose preemptive intravenous ibuprofen on postoperative opioid consumption and acute pain after laparoscopic cholecystectomy. Medicine (Baltimore). 2017 Feb;96(8):e6200. doi: 10.1097/MD.0000000000006200.
PubMed 28225506Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.
PubMed 26501533Gupta A, Abubaker H, Demas E, Ahrendtsen L. A Randomized Trial Comparing the Safety and Efficacy of Intravenous Ibuprofen versus Ibuprofen and Acetaminophen in Knee or Hip Arthroplasty. Pain Physician. 2016 Jul;19(6):349-56.
PubMed 27454264Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.
PubMed 29114833Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA. 2018 Mar 6;319(9):872-882. doi: 10.1001/jama.2018.0899.
PubMed 29509867Thybo KH, Hagi-Pedersen D, Dahl JB, Wetterslev J, Nersesjan M, Jakobsen JC, Pedersen NA, Overgaard S, Schroder HM, Schmidt H, Bjorck JG, Skovmand K, Frederiksen R, Buus-Nielsen M, Sorensen CV, Kruuse LS, Lindholm P, Mathiesen O. Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen vs Either Alone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty: The PANSAID Randomized Clinical Trial. JAMA. 2019 Feb 12;321(6):562-571. doi: 10.1001/jama.2018.22039.
PubMed 30747964Derry S, Derry CJ, Moore RA. Single dose oral ibuprofen plus oxycodone for acute postoperative pain in adults. Cochrane Database Syst Rev. 2013 Jun 26;2013(6):CD010289. doi: 10.1002/14651858.CD010289.pub2.
PubMed 23801549Cheung CW, Ching Wong SS, Qiu Q, Wang X. Oral Oxycodone for Acute Postoperative Pain: A Review of Clinical Trials. Pain Physician. 2017 Feb;20(2S):SE33-SE52.
PubMed 28226340
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Peri-Operative Pain Control Without Opioids
- ClinicalTrials.gov ID
- NCT04813991
- Acronym / sponsor ID
- PRO2020-0546
- Conditions
- Perioperative Pain
- Keywords
- Opioid Analgesic, Ibuprofen, Pain control, Acetaminophen, Laparoscopic Cholescystectomy, Laparoscopic Appendectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment was never initiated and the PI is leaving the institution so the study is closing.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adequate outpatient pain control after uncomplicated laparoscopic appendectomy or cholecystectomy can be achieved with minimal breakthrough drugs when used in combination with around the clock non-opioid medications.
Detailed description
Death from opioid overdose is now considered a national emergency. Prescribing of narcotics by physicians, particularly in the perioperative period, remains a significant contributor to opioid addiction. There is a critical need to identify post-operative pain control alternatives that eliminate narcotic usage. Without such information, clinicians will continue to rely on opioids to manage their patients' pain. Prior work supports the notion that there is little difference between the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) and that of opioid analgesics in controlling pain following surgical procedures. Recent clinical trials have concluded that a combination of centrally and peripherally acting analgesics improves patients' satisfaction and pain control. Clinical investigators have focused upon limiting opioid use rather than on eliminating the administration of narcotics. not surprisingly, there are no established evidenced-based guidelines for postoperative outpatient non-opioid pain control. The majority of U.S. surgeons continue to rely on opioids as the sole outpatient pain regimen, as suggested by a number of current guidelines.
Our observation is that adequate outpatient pain control after uncomplicated laparoscopic appendectomy or cholecystectomy can be achieved with minimal breakthrough drugs when used in combination with around the clock non-opioid medications.
The amount of opioids prescribed at discharge after laparoscopic appendectomies and cholecystectomies is quite variable. An average prescription is for 200-350 Oral Morphine Equivalents (OME) or 26-46 tabs of 5mg oxycodone with the lowest amount reported of 150 OME (20 tabs of 5mg oxy). One of the most conservative guidelines, the Michigan Surgical Quality Collaborative, recommends prescription of 75 OME after laparoscopic cholecystectomy
AIMS AND OBJECTIVES.
- Characterize the need for breakthrough pain medication in a cohort of post-operative subjects treated utilizing a 3-day pain regimen consisting of ibuprofen and acetaminophen for postoperative outpatient pain control without the use of opioids.
- Test the non-inferiority of a regimen consisting of ibuprofen when prescribed on as needed basis in controlling breakthrough pain compared with a regimen using oxycodone.
HYPOTHESIS
We predict that a non-opioid regimen can safely control post-operative pain as effectively as management protocols which include narcotics.
At the completion of the proposed research, our expected outcomes are to demonstrate that the ibuprofen/acetaminophen regimen provides adequate pain relief in patients who undergo uncomplicated laparoscopic cholecystectomy and appendectomy.
We also expect to have demonstrated that when breakthrough pain occurs, non-narcotic medications are as effective as opioids. These findings will be relevant to some 10 million surgeries per year in the U.S. where the patients may never need opioid exposure.
STUDY DESIGN/METHOLOGY
In this single-center, randomized, double-blind intervention trial, adult subjects will be enrolled after routine uncomplicated laparoscopic appendectomy or cholecystectomy for the management of outpatient pain. All participants will provide written informed consent.
All subjects will receive two oral analgesic medications (ibuprofen 600mg and acetaminophen 500mg) three times per day with meals, to consume for three days following discharge from the hospital. For breakthrough pain, with a double-blind approach with opaque capsules for the medications, subjects will be randomized to receive five packages of two pills containing either ibuprofen 600mg (Arm 1) or oxycodone 5mg(Arm 2). They will be instructed to consume breakthrough medications no more than twice per day.
The subjects will maintain a pain log and will record their pain intensity prior to meals each day, and also the maximum pain intensity for the given day, using a verbal pain Numerical Rating Scale (NRS) that ranges from 0 to 10.
A research team member will contact each subject daily by phone for seven days and confirm the subject is consuming their medications and collect information regarding pain intensity.
Subjects will be asked the following questions:
- To rate their pain on a scale of 0 to 10 daily, average and maximum.
- To report the # of breakthrough pain medication pills taken that day and how many total remain
If the subject reports a pain score of 8 or greater after taking the both breakthrough medications during a 24 hour period, they will be considered a study failure. Patient will be told to contact their surgeon for follow up. The research coordinator will follow up these subjects to confirm they have spoken to their treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Double-Blind Intervention Trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Ibuprofen Breakthrough | Experimental | Drug: Ibuprofen 600 mg600 mg Ibuprofen for breakthrough pain. |
| Arm 2 - Oxycodone Breakthrough | Active comparator | Drug: OxyCODONE 5 Mg Oral Capsule5 mg of Oxycodone for breakthrough pain. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18-90
- English or Spanish speaking
- Undergoing routine laparoscopic appendectomy or cholecystectomy
- Able to provide Informed Consent
Key exclusion criteria (14 listed)
- Current use of methadone
- Opioid use within 30 days prior to hospitalization
- Actively taking anti-inflammatory medications
- History of Adverse Reactions to Study Medications
- Pregnancy
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 |
|---|---|---|
| Ibuprofen 600 mgIbuprofen 600 mg for breakthrough pain. | Drug | Arm 1 - Ibuprofen Breakthrough |
| OxyCODONE 5 Mg Oral CapsuleOxyCODONE 5 Mg Oral Capsule for breakthrough pain. | Drug | Arm 2 - Oxycodone Breakthrough |
Primary outcome
Incidence of Breakthrough Pain
Time frame: 7 Days
The need for breakthrough pain medication will be characterized by the estimate of the incidence density for starting breakthrough medication. We will examine potential predictors of the need for breakthrough medication using an actuarial approach
1 secondary outcome
Time-weighted average daily pain score over first three days post-discharge.
Time frame: 3 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 28832871Gostin LO, Hodge JG Jr, Noe SA. Reframing the Opioid Epidemic as a National Emergency. JAMA. 2017 Oct 24;318(16):1539-1540. doi: 10.1001/jama.2017.13358. No abstract available.
- Background: PubMed 29746919Tan WH, Yu J, Feaman S, McAllister JM, Kahan LG, Quasebarth MA, Blatnik JA, Eagon JC, Awad MM, Brunt LM. Opioid Medication Use in the Surgical Patient: An Assessment of Prescribing Patterns and Use. J Am Coll Surg. 2018 Aug;227(2):203-211. doi: 10.1016/j.jamcollsurg.2018.04.032. Epub 2018 May 7.
- Background: PubMed 30983590Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. Lancet. 2019 Apr 13;393(10180):1547-1557. doi: 10.1016/S0140-6736(19)30428-3.
- Background: PubMed 9212119White PF, Joshi GP, Carpenter RL, Fragen RJ. A comparison of oral ketorolac and hydrocodone-acetaminophen for analgesia after ambulatory surgery: arthroscopy versus laparoscopic tubal ligation. Anesth Analg. 1997 Jul;85(1):37-43. doi: 10.1097/00000539-199707000-00007.
- Background: PubMed 15763605Singla N, Pong A, Newman K; MD-10 Study Group. Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of pain after abdominal or pelvic surgery in women: a randomized, double-blind, placebo- and active-controlled parallel-group study. Clin Ther. 2005 Jan;27(1):45-57. doi: 10.1016/j.clinthera.2005.01.010.
- Background: PubMed 18308218Mitchell A, van Zanten SV, Inglis K, Porter G. A randomized controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine after outpatient general surgery. J Am Coll Surg. 2008 Mar;206(3):472-9. doi: 10.1016/j.jamcollsurg.2007.09.006. Epub 2007 Nov 26.
- Background: PubMed 20642488Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.
- Background: PubMed 28225506Ahiskalioglu EO, Ahiskalioglu A, Aydin P, Yayik AM, Temiz A. Effects of single-dose preemptive intravenous ibuprofen on postoperative opioid consumption and acute pain after laparoscopic cholecystectomy. Medicine (Baltimore). 2017 Feb;96(8):e6200. doi: 10.1097/MD.0000000000006200.
- Background: PubMed 26501533Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.
- Background: PubMed 27454264Gupta A, Abubaker H, Demas E, Ahrendtsen L. A Randomized Trial Comparing the Safety and Efficacy of Intravenous Ibuprofen versus Ibuprofen and Acetaminophen in Knee or Hip Arthroplasty. Pain Physician. 2016 Jul;19(6):349-56.
- Background: PubMed 29114833Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.
- Background: PubMed 29509867Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA. 2018 Mar 6;319(9):872-882. doi: 10.1001/jama.2018.0899.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen 600 mg and OxyCODONE 5 Mg Oral Capsule in people with Perioperative Pain, run by Hackensack Meridian Health 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 14 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: withdrawn, as of the sponsor's last update on 10 Sep 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of Breakthrough Pain (time frame: 7 Days). 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 NCT04813991, which also lists 23 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 10 Sep 2022.