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Local Anesthetic
Right sided catheter normal saline and left sided catheter bupivacaine 0.25% for Postoperative Pain
Phase 4
Waitlist Available
Led By Brian M Ilfeld, MD,MS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative day 2 (00:01 through afternoon data-collection time point)
Awards & highlights
Study Summary
This study is evaluating whether a catheter and infusion of local anesthetic can increase the duration of the effects of a single-injection ESP block.
Eligible Conditions
- Postoperative Pain
- Surgical Incisions
- Acute Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
"Average" pain during postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale
Secondary outcome measures
"Average" pain during postoperative day 2 which is the "average" pain measured using the numeric rating scale, collected postoperative day 2 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10=worst pain
"Average" pain during postoperative day 3 which is the "average" pain measured using the numeric rating scale, collected postoperative day 3 for the time since midnight. It is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst pain
"Current" pain during postoperative days 1-3 which is the current pain experienced using the numeric rating scale, collected postoperative days 1-3. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain
+7 moreOther outcome measures
Antiemetic use
Hospital length of stay
Indication for surgery
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Right sided catheter normal saline and left sided catheter bupivacaine 0.25%Experimental Treatment2 Interventions
This is a split body study. Bilateral erector spinae plane catheters will be inserted and study fluid is administered bilaterally. Normal saline will be administered through the right-sided catheter while bupivacaine 0.25% will be administered through the left-sided catheter. Both infusion pumps will be programmed to deliver a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.
Group II: Right sided catheter bupivacaine 0.25% and left sided catheter normal salineExperimental Treatment2 Interventions
This is a split body study. Bilateral erector spinae plane catheters will be inserted and study fluid is administered bilaterally. Bupivacaine 0.25 will be administered through the right-sided catheter while normal saline will be administered through the left-sided catheter. Both infusion pumps will be programmed to deliver a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine 0.25%
2016
Completed Phase 4
~950
Normal Saline
2019
Completed Phase 4
~1770
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,407 Total Patients Enrolled
6 Trials studying Postoperative Pain
401 Patients Enrolled for Postoperative Pain
Brian M Ilfeld, MD,MSPrincipal InvestigatorUCSD Medical Center
1 Previous Clinical Trials
138 Total Patients Enrolled
Frequently Asked Questions
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