Pain Control Without Opioids

September 7, 2022 updated by: Hackensack Meridian Health

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

  1. 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.
  2. 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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - Ibuprofen Breakthrough
600 mg Ibuprofen for breakthrough pain.
Drug: Ibuprofen 600 mg
Ibuprofen 600 mg for breakthrough pain.
Active Comparator: Arm 2 - Oxycodone Breakthrough
5 mg of Oxycodone for breakthrough pain.
Drug: OxyCODONE 5 Mg Oral Capsule
OxyCODONE 5 Mg Oral Capsule for breakthrough pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-weighted average daily pain score over first three days post-discharge.
Time Frame: 3 Days
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.
3 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2022

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO2020-0546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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