Article Text

Download PDFPDF

Relieving acute pain (RAP) study: a proof-of-concept protocol for a randomised, double-blind, placebo-controlled trial
  1. Luana Colloca1,
  2. Se Eun Lee1,
  3. Meghan Nichole Luhowy2,
  4. Nathaniel Haycock1,
  5. Chika Okusogu1,
  6. Soojin Yim1,
  7. Nandini Raghuraman1,
  8. Robert Goodfellow3,
  9. Robert Scott Murray3,
  10. Patricia Casper3,
  11. Myounghee Lee4,
  12. Thomas Scalea3,
  13. Yvette Fouche5,
  14. Sarah Murthi3
  1. 1 Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA
  2. 2 Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, Maryland, USA
  3. 3 R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, Maryland, USA
  4. 4 Investigational Drug Services, University of Maryland Medical Center, Baltimore, Maryland, USA
  5. 5 Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, Maryland, USA
  1. Correspondence to Professor Luana Colloca; colloca{at}umaryland.edu

Abstract

Introduction Physicians and other prescribing clinicians use opioids as the primary method of pain management after traumatic injury, despite growing recognition of the major risks associated with usage for chronic pain. Placebos given after repeated administration of active treatments can acquire medication-like effects based on learning mechanisms. This study hypothesises that dose-extending placebos can be an effective treatment in relieving clinical acute pain in trauma patients who take opioids.

Methods and analysis The relieving acute pain is a proof-of-concept randomised, placebo-controlled, double-blinded, single-site study enrolling 159 participants aged from 18 to 65 years with one or more traumatic injuries treated with opioids. Participants will be randomly assigned to three different arms. Arm 1 will receive the full dose of opioids with non-steroidal anti-inflammatory drugs (NSAIDs). Arm 2 will receive the 50% overall reduction in opioid dosage, dose-extending placebos and NSAIDs. Arm 3 (control) will receive NSAIDs and placebos. The trial length will be 3 days of hospitalisation (phase I) and 2-week, 1-month, 3-month and 6-month follow-ups (exploratory phase II). Primary and secondary outcomes include feasibility and acceptability of the study. Pain intensity, functional pain, emotional distress, rates of rescue therapy requests and patient-initiated medication denials will be collected.

Ethics and dissemination All activities associated with this protocol are conducted in full compliance with the Institutional Review Board policies and federal regulations. Publishing this study protocol will enable researchers and funding bodies to stay up to date in their fields by providing exposure to research activity that may not otherwise be widely publicised.

Date and protocol version identifier 3/6/2019 (HP-00078742).

Trial registration number NCT03426137.

  • opioid
  • dose-extending placebo
  • pharmacological conditioning
  • pain interference
  • functional pain
  • emotional distress

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

View Full Text

Statistics from Altmetric.com

Footnotes

  • Contributors LC, YF, TS, PC, SEL, CO, NH and SM designed the study; ML and LC took care of the strategies for the drug manufacturing and bedside delivery of the treatments; LC, SM, PC, RG, RSM and YF created the criteria of inclusion/exclusion; TS provided critical feedback on the manuscript; SY, NR, RSM, NH, CO and SEL designed the research tools from creating of the CRF to programming the scripts for text messaging the patients; NH, RSM, RG and LC ran the training of the nurses and physicians; SEL, NH and LC prepared the IRB protocol and ClinicalTrials.gov documents; SEL, CO and MNL drafted the first version of the manuscript; SEL, SM, TS, YF and LC completed the revision of the manuscript. All the authors reviewed and agreed with the latest version.

  • Funding This work was funded by the Agency for Healthcare Research and Quality (R24HS022135), MPowering the State: Strategic Partnership Grant (LC) to conduct clinical research related to new approaches to taper opioids for the management of acute pain.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.