Role of Opioids in Epidural Solutions

Study Overview
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Brief Summary
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It is unclear whether addition of opioids to epidural solutions for postoperative analgesia is beneficial. In this multicenter randomized double-blinded trial, we aim to test the primary hypothesis that epidural solutions containing only bupivacaine are as effective as solutions containing both bupivacaine and fentanyl in promoting analgesia in patients recovering from open abdominal surgery. We also aim to assess the incidence of epidural-induced hypotension, the difference in patient-reported opioid side-effects between the two groups. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to substantially reduce the amount of opioids patients receive during their postoperative recovery, and potentially decrease the associated high incidence of opioid adverse effects in post-surgical patients.

Official Title
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The Role of Epidural Opioids in Pain Management After Abdominal Surgery in Adult Patients - a Randomized Clinical Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent 18-85 years old Undergoing open abdominal surgery (including colorectal, intestinal, gastric, pancreatic, hepatobiliary, urological, or gynecological surgery) For which a clinical decision has been made to provide epidural analgesia preoperatively and extending to the post-operative period Anticipated hospitalization of at least 2 nights Exclusion Criteria: Known allergy to bupivacaine or fentanyl Chronic liver disease, defined as cirrhosis, portal hypertension, or variceal bleeding Patients under chronic alpha-blocking agents for hypertension Clinical contraindications to epidural introduction, as judged by the anesthesia provider (thrombocytopenia, un-interrupted anticoagulation, clinically-significant atrio-ventricular conduction block, etc.) Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine<br>Epidural solution containing 0.1% bupivaacaine in normal saline | Drug: Bupivacaine<br>* epidural solution containing bupivacaine 0.1% in normal saline<br>* Other names: Marcaine;|
| Experimental: Bupivacaine + Fentanyl<br>Epidural solution containing 0.1% bupivacaine and 3 mcg/ml of fentanyl in normal saline | Drug: Bupivacaine<br>* epidural solution containing bupivacaine 0.1% in normal saline<br>* Other names: Marcaine;Drug: Fentanyl<br>* Epidural solution containing fentanyl 3 mcg/ml (in addition to bupivacaine) in normal saline<br>* Other names: Beatryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesia | A joint outcome of the difference in average pain score and a ratio of opioid consumption (in mg morphine equivalents) between the 2 study groups | 48 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically significant postoperative hypotension | Number of participants experiencing a composite of use of IV fluid boluses prescribed for hemodynamic support; sympathomimetic drugs administration; and holding or early discontinuation of the epidural infusion in order to recover blood pressure. | 48 postoperative hours |