Phase 4
N=120
Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.
Pain, Acute
Bottom Line
View on ClinicalTrials.gov: NCT03307174 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Total Local Anesthetic Utilized in First 24 Hours — 126; 123 mg — p=0.74
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine (Drug); Fentanyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Local Anesthetic Utilized in First 24 Hours |
126; 123 | 0.74 |
| SECONDARY Total Opioid Consumed |
12; 16; 0; 0; 0; 1 | — |
| SECONDARY Patient Satisfaction Score |
9; 8; 9; 9; 9; 9 | — |
| SECONDARY Average Pain Severity |
3; 5; 3; 2; 3; 3 | — |
| SECONDARY Incidence of Hypotension |
9; 18 | — |
| SECONDARY Worst Reported 24 Hour Pain |
5; 8; 6; 6; 7; 6 | — |
| SECONDARY Average Pain Interference |
2; 3; 1; 1; 2; 1 | — |
Summary
Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior studies in labor epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia can improve pain control by reducing the amount of local anesthetic required as well as improve patient satisfaction when compared to continuous epidural infusions. The effects of programmed intermittent bolus of epidural local anesthetics compared to continuous epidural infusions in a surgical setting have yet to be elucidated. Our goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a surgical patient population. We plan to enroll patients already undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology, urological where epidural anesthesia can be employed. The primary endpoints of the study will be the total local anesthetic consumption and total opioid consumption as surrogate markers for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesia physical classification I - III, scheduled for surgery with anticipated an epidural anesthesia (including but not limited to colorectal, surgical oncology, urology, gynecology) as part of their perioperative treatment
Exclusion Criteria
- Age younger than 18 years of age, non-English speaking, contraindication for neuraxial anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to local anesthetic), preexisting neurologic deficits, inability to consent due to cognitive dysfunction, patients with pain numeric rating score > 5 each day for greater than 3 months, daily opioid consumption > 100 oral morphine equivalents for 14 consecutive days prior to surgery, patient refusal.
Data sourced from ClinicalTrials.gov (NCT03307174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.