Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery

NCT03679013 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 18-3002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The Inova Heart and Vascular Institute (IHVI) perform over 300 coronary artery bypass graft (CABG) surgeries per year. While opioid medications are the institutional standard of care for post-operative pain therapy little is known about the variation in pain scores, incidence of post- operative complications, and cost of hospitalization when an alternative multimodal pain regimen consisting of oral Gabapentin and intravenous Acetaminophen (IV APAP) is utilized. The objective is to determine whether there is a substantial difference in pain scores, incidence of post-operative complications, and costs associated with hospitalization when a non-opioid multimodal pain regimen is utilized A single- center, open label, prospective, randomized, controlled clinical trial comprised of 20 total patients who have undergone isolated CABG at the IHVI will be conducted. Separate cohorts will include patients receiving opioid medications post-operatively (Group 1) and patients receiving the non-opioid regimen of oral Gabapentin and IV APAP (Group 2) to be followed for 72 hours post CABG surgery. Main outcome measures include pain scores in both study groups, requests for breakthrough pain medication in both groups, gastrointestinal and respiratory complications of ileus and reduction in tidal volumes or forced vital capacity (FVC) at baseline and at 72 hours,increase in serum AST/ALT, and comparison of cost of hospitalization between groups. The objective of this pilot study is to provide evidence that multimodal pain therapy utilizing IV APAP and PO Gabapentin will provide more effective pain relief than standard of care opioids as evidenced by pain scores \<2. And the reduced consumption of opioids will lead to a reduction in ileus, no increase in AST/ALT, post-operative tidal volumes as assessed by incentive spirometry comparable to pre- surgical values, while also showing a positive effect on the cost of hospitalization.

Conditions

Pain, Postoperative

Keywords

cardiac; surgery; pain

Outcome Measures

Primary Outcomes (2)

• The Number of Patients With Requests for Breakthrough Opioid Pain Medication in Opioid Standard of Care Regimen Compared to Non-opioid Multimodal Pain Relief Regimen (Experimental Group).

  Number of patients with requests for breakthrough pain medication. Requests for breakthrough pain medication is defined as having pain scores \>4 using the Numeric Rating Scale: a dimensional measurement of pain intensity; 0-10 scale for scoring pain (0= "no pain", 10"worst pain imaginable")

  24 hours, 48 hours, 72 hours after post-surgical treatment

• Average Pain Score at 24, 48 and 72 Hours Post-operatively

  Participants were assessed by rating their pain according to the Numeric Rating Scale: a dimensional measurement of pain intensity; 0-10 scale for scoring pain (0= "no pain", 10="worst pain imaginable") The minimum and maximum pain scores per participant were aggregated at timepoints of 24 hours, 48 hours, and 72 hours after the start of post-operative treatment

  at 24, 48, and 72 hours after the start of post-operative treatment

Secondary Outcomes (1)

• Number of Participants With Ileus During Hospitalization

  Surgery completion through study completion up to one week.

Study Arms (2)

Opioid based standard of care regimen.

OTHER

Inova Heart and Vascular Institute (IHVI) opioid based standard of care regimen given for post operative cardiac surgery pain.

Drug: Opiate based pain regimen.

Opioid sparing pain regimen.

EXPERIMENTAL

Multimodal pain regimen consisting of PO Gabapentin paired with intravenous Acetaminophen given for post operative cardiac surgery pain.

Drug: Oral Gabapentin and Intravenous Acetaminophen (IV APAP)

Interventions

Oral Gabapentin and Intravenous Acetaminophen (IV APAP) DRUG

Scheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery.

Also known as: PO Gabapentin and IV APAP

Opioid sparing pain regimen.

Opiate based pain regimen. DRUG

Standard of care opiate based pain regimen.

Also known as: Post operative opioids

Opioid based standard of care regimen.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient between 18 and 85 years old.
• Elective or urgent surgery requiring sternotomy approach
• Subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information (PHI) approved by the Inova Institutional Review Board (IRB).

You may not qualify if:

• Patients lacking enteral access on post-operative day 0
• Inability to communicate
• Active chronic pain with opioid therapy
• Active chronic use of gabapentin or pregabalin
• Active substance abuse
• Current self- report of alcoholism
• End stage renal disease
• Active renal dialysis therapy

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Heart and Vascular institute

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Ramesh Singh, MD
• Organization: Inova Fairfax Hospital

ramesh.singh@inova.org

(703)776-8025

Study Officials

• Ramesh Singh, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiothoracic Surgeon

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 20, 2018
• Study Start: April 19, 2019
• Primary Completion: July 12, 2019
• Study Completion: July 12, 2019
• Last Updated: November 8, 2022
• Results First Posted: November 8, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)