University of California San Francisco
San Francisco, California, 94158, United States
NCT Number: NCT03307174
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
San Francisco, California, 94158, United States
See brief summary
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: 0.0625% bupivacaine
Other names: 2mcg/ml fentanyl
Time frame: In first 24 hours
Total local anesthetic consumed while epidural in place, recorded on infusion pump
Time frame: While epidural in place (up to 72 hours post operatively)
Total opioid consumed (intravenous or po) while epidural in place
Time frame: While epidural in place (up to 72 hours postoperatively)
Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory.
Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.
Time frame: While epidural in place (up to 72 hours postoperatively)
Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.
Time frame: While epidural in place (24 hours postoperatively)
Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.
Time frame: While epidural in place (up to 72 hours postoperatively)
Minimum is 0, maximum is 10. 10 indicates highest pain severity.
Time frame: While epidural in place (up to 72 hours postoperatively)
Minimum is 0, maximum is 10. 10 indicates highest pain interference.
University of California, San Francisco
Other
A Prospective, Randomized Analysis of Epidural Anesthesia Using Programmed Intermittent Epidural Boluses Versus Continuous Epidural Infusion in Patients Undergoing Abdominal Surgery.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT05476575
Acute Pain, Neurologic Manifestations
New Taipei City, Taiwan
View Trial DetailsNCT06062108
Acute Pain, Chronic Pain
Draguignan, Var, France
View Trial DetailsNCT07249827
Acute Pain, Agnosia
Montreal, Quebec, Canada
View Trial Details