Postoperative Pain
Conditions
Brief summary
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.
Interventions
DRUGBupivacaine
epidural solution containing bupivacaine 0.1% in normal saline
DRUGFentanyl
Epidural solution containing fentanyl 3 mcg/ml (in addition to bupivacaine) in normal saline
Sponsors
Israel Society of Anesthesiologists
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. 18-85 years old 3. Undergoing open abdominal surgery (including colorectal, intestinal, gastric, pancreatic, hepatobiliary, urological, or gynecological surgery) 4. For which a clinical decision has been made to provide epidural analgesia preoperatively and extending to the post-operative period 5. Anticipated hospitalization of at least 2 nights
Exclusion criteria
1. Known allergy to bupivacaine or fentanyl 2. Chronic liver disease, defined as cirrhosis, portal hypertension, or variceal bleeding 3. Patients under chronic alpha-blocking agents for hypertension 4. Clinical contraindications to epidural introduction, as judged by the anesthesia provider (thrombocytopenia, un-interrupted anticoagulation, clinically-significant atrio-ventricular conduction block, etc.) 5. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative analgesia | 48 postoperative hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant postoperative hypotension | 48 postoperative hours | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Recovery of gastrointestinal function | Throughout the postoperative hospital stay, up to 30 days | Time to first postoperative bowel movement |
| Opioid-related side effects | 48 postoperative hours | A composite of opioid-related side-effects as measured by the Opioid-Related Symptom Distress Scale (OR-SDS) questionnaire (higher scores represent more side-effects and related distress, scores are given on multiple dimensions) |
Countries
Israel
Outcome results
None listed