Pain Control Without Opioids

NCT04813991 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: PRO2020-0546
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perioperative Pain

Keywords

Opioid Analgesic; Ibuprofen; Pain control; Acetaminophen; Laparoscopic Cholescystectomy; Laparoscopic Appendectomy

Outcome Measures

Primary Outcomes (1)

• 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

  7 Days

Secondary Outcomes (1)

• Time-weighted average daily pain score over first three days post-discharge.

  3 Days

Study Arms (2)

Arm 1 - Ibuprofen Breakthrough

EXPERIMENTAL

600 mg Ibuprofen for breakthrough pain.

Drug: Ibuprofen 600 mg

Arm 2 - Oxycodone Breakthrough

ACTIVE COMPARATOR

5 mg of Oxycodone for breakthrough pain.

Drug: OxyCODONE 5 Mg Oral Capsule

Interventions

Ibuprofen 600 mg DRUG

Ibuprofen 600 mg for breakthrough pain.

Arm 1 - Ibuprofen Breakthrough

OxyCODONE 5 Mg Oral Capsule DRUG

OxyCODONE 5 Mg Oral Capsule for breakthrough pain.

Arm 2 - Oxycodone Breakthrough

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-90
• English or Spanish speaking
• Undergoing routine laparoscopic appendectomy or cholecystectomy
• Able to provide Informed Consent

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (23)

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• Tan 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.

  PMID: 29746919 BACKGROUND

• Neuman 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.

  PMID: 30983590 BACKGROUND

• White 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.

  PMID: 9212119 BACKGROUND

• Singla 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.

  PMID: 15763605 BACKGROUND

• Mitchell 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.

  PMID: 18308218 BACKGROUND

• Kroll 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.

  PMID: 20642488 BACKGROUND

• Ahiskalioglu 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.

  PMID: 28225506 BACKGROUND

• Friedman 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.

  PMID: 26501533 BACKGROUND

• Gupta 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.

  PMID: 27454264 BACKGROUND

• Chang 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.

  PMID: 29114833 BACKGROUND

• Krebs 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.

  PMID: 29509867 BACKGROUND

• Thybo 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.

  PMID: 30747964 BACKGROUND

• Derry 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.

  PMID: 23801549 BACKGROUND

• Cheung 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.

  PMID: 28226340 BACKGROUND

• Feinberg AE, Chesney TR, Srikandarajah S, Acuna SA, McLeod RS; Best Practice in Surgery Group. Opioid Use After Discharge in Postoperative Patients: A Systematic Review. Ann Surg. 2018 Jun;267(6):1056-1062. doi: 10.1097/SLA.0000000000002591.

  PMID: 29215370 BACKGROUND

• Ladha KS, Neuman MD, Broms G, Bethell J, Bateman BT, Wijeysundera DN, Bell M, Hallqvist L, Svensson T, Newcomb CW, Brensinger CM, Gaskins LJ, Wunsch H. Opioid Prescribing After Surgery in the United States, Canada, and Sweden. JAMA Netw Open. 2019 Sep 4;2(9):e1910734. doi: 10.1001/jamanetworkopen.2019.10734.

  PMID: 31483475 BACKGROUND

• Hanson KT, Thiels CA, Polites SF, Gazelka HM, Ray-Zack MD, Zielinski MD, Habermann EB. The opioid epidemic in acute care surgery-Characteristics of overprescribing following laparoscopic cholecystectomy. J Trauma Acute Care Surg. 2018 Jul;85(1):62-70. doi: 10.1097/TA.0000000000001834.

  PMID: 29462081 BACKGROUND

• Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.

  PMID: 27631771 BACKGROUND

• Michigan OPEN. Opioid Prescribing Recommendations for Opioid-Naive Patients. https://opioidprescribing.info. Published 2018. Accessed September 17, 2019.

  BACKGROUND

• Sim V, Hawkins S, Gave AA, Bulanov A, Elabbasy F, Khoury L, Panzo M, Sim E, Cohn S. How low can you go: Achieving postoperative outpatient pain control without opioids. J Trauma Acute Care Surg. 2019 Jul;87(1):100-103. doi: 10.1097/TA.0000000000002295.

  PMID: 31259870 BACKGROUND

• Ayad S, Babazade R, Elsharkawy H, Nadar V, Lokhande C, Makarova N, Khanna R, Sessler DI, Turan A. Comparison of Transversus Abdominis Plane Infiltration with Liposomal Bupivacaine versus Continuous Epidural Analgesia versus Intravenous Opioid Analgesia. PLoS One. 2016 Apr 15;11(4):e0153675. doi: 10.1371/journal.pone.0153675. eCollection 2016.

  PMID: 27082959 BACKGROUND

• Turan A, Atim A, Dalton JE, Keeyapaj W, Chu W, Bernstein E, Fu A, Jae Ho L, Saager L, Sessler DI. Preoperative angiotensin-converting enzyme inhibitor use is not associated with increased postoperative pain and opioid use. Clin J Pain. 2013 Dec;29(12):1050-6. doi: 10.1097/AJP.0b013e318287a258.

  PMID: 24189772 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ibuprofen; Oxycodone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Double-Blind Intervention Trial

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: March 15, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)