Pain, PostoperativePhase 2INOVAOPIOIDNCT03679013
Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery
A Phase 2 study testing Oral Gabapentin and Intravenous Acetaminophen (IV APAP) and Opiate based pain regimen. in people with Pain, Postoperative, run by Inova Health Care Services at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Oral Gabapentin and Intravenous Acetaminophen (IV APAP) and Opiate based pain regimen.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2019to 12 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Heart and Vascular institute
Falls Church, Virginia, 22042
About this study
Official title: A Pilot Study Comparing the Effectiveness of an Opioid- Sparing Analgesic Regimen and an Opioid Based Regimen on Post- Operative Pain Control in Cardiac Surgery Patients (INOVA OPIOID
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.
Read more
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.
Read the detailed description
The Cardiovascular Intensive Care Unit (CVICU) of the Inova Heart and Vascular Institute (IHVI) will be the setting of this clinical trial involving two groups of subjects and comparing the opiate based standard of care regimen currently adopted (Group 1) at the IHVI with a treatment group (Group 2). Group 2 will receive a scheduled multimodal pain regimen consisting of PO (pro ora [oral]) Gabapentin paired with intravenous Acetaminophen. Opioids will be available for breakthrough pain in the treatment group for pain scores greater than 4. The outcomes of total opioid consumption and minimum/ maximum pain scores will be assessed at the 24 hours, 48 hours, 72 hours, and PRN (pro re nata [as the situation demands]) timepoints. Assessment will include amount of opioids consumed in both groups as well as number of requests for breakthrough pain medication in Group 2.
Minimum and maximum pain scores in all study groups will be assessed via Numeric Rating Scale (0-10) as per Inova Health System (IHS) policy; 'Pain Management for the Adult Population', at 24 hours, 48 hours, 72 hours, and PRN with opioid requests in all groups and opioid administration follow up within one hour as per IHS inpatient medication administration policy. Follow up medication administration scores will not be recorded as part of study results.
Secondary assessments will include the incidence of ileus both during hospitalization, increase in aspartate aminotransferase (AST)/ alanine aminotransferase (ALT), post-operative tidal volumes as assessed by incentive spirometry as compared to pre- surgical values, time from Cardiovascular Intensive Care Unit (CVICU) arrival to extubation in both groups, and the effects of an opioid based regimen versus an opioid sparing regimen on cost of medication and hospitalization.
The investigators hypothesize that a scheduled opioid- sparing pain regimen consisting of intravenous Acetaminophen IV APAP and PO Gabapentin for 48 hours post- operatively will reduce opioid consumption while maintaining adequate pain relief as evidenced by pain scores less than two (2), and a reduction in opioid consumption, and that reduced opioid consumption will lead to a reduction in the incidence of ileus, an opioid related side effect, no increase in AST/ALT, post-operative tidal volumes as assessed by incentive spirometry comparable to pre- surgical values, and demonstrate a positive effect on the cost of medication and hospitalization.
- Conditions
- Pain, Postoperative
- Being tested
- Oral Gabapentin and Intravenous Acetaminophen (IV APAP), Opiate based pain regimen.
- Keywords
- cardiac, surgery, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Gabapentin and Intravenous Acetaminophen (IV APAP)Drug
Also called PO Gabapentin and IV APAP
Scheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery.
Opiate based pain regimen.Drug
Also called Post operative opioids
Standard of care opiate based pain regimen.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oral Gabapentin and Intravenous Acetaminophen (IV APAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 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
Measured: at 24, 48, and 72 hours after the start of post-operative treatment
Secondary outcomes (1)
Number of Participants With Ileus During Hospitalization
The number of participants with occurrences of ileus during hospitalization.
Measured: Surgery completion through study completion up to one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start19 Apr 2019
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramesh Singh, Inova Health Care Services
- Investigators
- Ramesh Singh, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679013
- Sponsor's protocol ID
- 18-3002
- Acronym
- INOVAOPIOID
- Status last verified
- Oct 2022
- First submitted
- 5 Sep 2018
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing the Effectiveness of an Opioid- Sparing Analgesic Regimen and an Opioid Based Regimen on Post- Operative Pain Control in Cardiac Surgery Patients (INOVA OPIOID
- ClinicalTrials.gov ID
- NCT03679013
- Acronym / sponsor ID
- INOVAOPIOID / 18-3002
- Conditions
- Pain, Postoperative
- Keywords
- cardiac, surgery, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Posted 8 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Cardiovascular Intensive Care Unit (CVICU) of the Inova Heart and Vascular Institute (IHVI) will be the setting of this clinical trial involving two groups of subjects and comparing the opiate based standard of care regimen currently adopted (Group 1) at the IHVI with a treatment group (Group 2). Group 2 will receive a scheduled multimodal pain regimen consisting of PO (pro ora [oral]) Gabapentin paired with intravenous Acetaminophen. Opioids will be available for breakthrough pain in the treatment group for pain scores greater than 4. The outcomes of total opioid consumption and minimum/ maximum pain scores will be assessed at the 24 hours, 48 hours, 72 hours, and PRN (pro re nata [as the situation demands]) timepoints. Assessment will include amount of opioids consumed in both groups as well as number of requests for breakthrough pain medication in Group 2.
Minimum and maximum pain scores in all study groups will be assessed via Numeric Rating Scale (0-10) as per Inova Health System (IHS) policy; 'Pain Management for the Adult Population', at 24 hours, 48 hours, 72 hours, and PRN with opioid requests in all groups and opioid administration follow up within one hour as per IHS inpatient medication administration policy. Follow up medication administration scores will not be recorded as part of study results.
Secondary assessments will include the incidence of ileus both during hospitalization, increase in aspartate aminotransferase (AST)/ alanine aminotransferase (ALT), post-operative tidal volumes as assessed by incentive spirometry as compared to pre- surgical values, time from Cardiovascular Intensive Care Unit (CVICU) arrival to extubation in both groups, and the effects of an opioid based regimen versus an opioid sparing regimen on cost of medication and hospitalization.
The investigators hypothesize that a scheduled opioid- sparing pain regimen consisting of intravenous Acetaminophen IV APAP and PO Gabapentin for 48 hours post- operatively will reduce opioid consumption while maintaining adequate pain relief as evidenced by pain scores less than two (2), and a reduction in opioid consumption, and that reduced opioid consumption will lead to a reduction in the incidence of ileus, an opioid related side effect, no increase in AST/ALT, post-operative tidal volumes as assessed by incentive spirometry comparable to pre- surgical values, and demonstrate a positive effect on the cost of medication and hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid based standard of care regimen. | Other | Drug: Opiate based pain regimen.Inova Heart and Vascular Institute (IHVI) opioid based standard of care regimen given for post operative cardiac surgery pain. |
| Opioid sparing pain regimen. | Experimental | Drug: Oral Gabapentin and Intravenous Acetaminophen (IV APAP)Multimodal pain regimen consisting of PO Gabapentin paired with intravenous Acetaminophen given for post operative cardiac surgery pain. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Oral Gabapentin and Intravenous Acetaminophen (IV APAP)Also: PO Gabapentin and IV APAPScheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery. | Drug | Opioid sparing pain regimen. |
| Opiate based pain regimen.Also: Post operative opioidsStandard of care opiate based pain regimen. | Drug | Opioid based standard of care regimen. |
Primary outcome
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).
Time frame: 24 hours, 48 hours, 72 hours after post-surgical treatment
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")
Average Pain Score at 24, 48 and 72 Hours Post-operatively
Time frame: at 24, 48, and 72 hours after the start of post-operative treatment
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
1 secondary outcome
Number of Participants With Ileus During Hospitalization
Time frame: Surgery completion through study completion up to one week.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Ramesh Singh, MD principal investigator
Inova Health Care Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Gabapentin and Intravenous Acetaminophen (IV APAP) and Opiate based pain regimen. in people with Pain, Postoperative, run by Inova Health Care Services 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 8 Nov 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). (time frame: 24 hours, 48 hours, 72 hours after post-surgical treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2022.