Clinical trial NCT03307174: Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.
Official title: A Prospective, Randomized Analysis of Epidural Anesthesia Using Programmed Intermittent Epidural Boluses Versus Continuous Epidural Infusion in Patients Undergoing Abdominal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: See brief summary

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.

Primary outcomes:
measure: Total Local Anesthetic Utilized in First 24 Hours
timeFrame: In first 24 hours
Secondary outcomes:
measure: Total Opioid Consumed
timeFrame: While epidural in place (up to 72 hours post operatively)
measure: Patient Satisfaction Score
timeFrame: While epidural in place (up to 72 hours postoperatively)
measure: Average Pain Severity
timeFrame: While epidural in place (up to 72 hours postoperatively)
measure: Incidence of Hypotension
timeFrame: While epidural in place (24 hours postoperatively)
measure: Worst Reported 24 Hour Pain
timeFrame: While epidural in place (up to 72 hours postoperatively)
measure: Average Pain Interference
timeFrame: While epidural in place (up to 72 hours postoperatively)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Matthias Behrends, MD
role: PRINCIPAL_INVESTIGATOR
References: