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Liposomal Bupivicaine in TAP block for Postoperative Pain
Phase 3
Waitlist Available
Led By Heidi Ching, MD
Research Sponsored by Abington Memorial Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
all patients undergoing planned exploratory laparotomy
TAP blocks placed after the laparotomy incision is closed, but before the patient is awake, and placed under ultrasound guidance with correct identification of the correct abdominal plane.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, expected to be approximately 1 year in total
Awards & highlights
Study Summary
This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the hospital, total narcotic use, and overall complications rates.
Eligible Conditions
- Gynecologic Cancers
- Postoperative Pain
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, expected to be approximately 1 year in total
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, expected to be approximately 1 year in total
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of stay post operatively in hospital
Secondary outcome measures
total opioid use post operatively in hospital
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal Bupivicaine in TAP blockExperimental Treatment1 Intervention
When performing a bilateral TAP with liposomal bupivacaine and the incision is below the umbilicus: the 20 ml vial of liposomal bupivacaine containing 266 mg, will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.
Group II: Bupivacaine HCl in TAP blockActive Control1 Intervention
When performing a bilateral TAP with Bupivicaine 0.25% and the incision is below the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials).
When performing a bilateral TAP with Bupivicaine 0.25% and the incision extends above the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). A 3rd vial of 30 ml 0.25% bupivacaine will be drawn up and is directly infiltrated into the surgical site (above and below the fascia prior to closure of fascia) extending above the umbilicus by the surgeon.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Find a Location
Who is running the clinical trial?
Abington Memorial HospitalLead Sponsor
11 Previous Clinical Trials
3,987 Total Patients Enrolled
1 Trials studying Postoperative Pain
200 Patients Enrolled for Postoperative Pain
Heidi Ching, MDPrincipal InvestigatorOB GYN Resident
Frequently Asked Questions
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