A Comparison of Exparel to Bupivacaine in TAP Block for Abdominal Gynecologic Surgery
NCT ID: NCT03304444
Last Updated: 2017-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
128 participants
INTERVENTIONAL
2016-08-31
2017-10-31
Brief Summary
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Detailed Description
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Currently, patients on the gynecologic oncology service undergoing major abdominal surgery are receiving a type of regional anesthesia using bupivacaine HCl known as a TAP block as part of an effort to decrease narcotic use post-operatively and decrease hospital length of stay. Bupivacaine has a known eight to twelve hour duration of action, thus addressing immediate post operative pain. As Exparel™ is anticipated to have a longer duration of action, the purpose of this study is to determine if TAP blocks with Exparel™ have an advantage over standard TAP blocks with bupivacaine HCl in reducing length of hospital stay in a randomized controlled trial. Our hypothesis is that TAP blocks with Exparel™ will result in reduced length of stay contributing to significant hospital cost savings. Secondary outcomes include total narcotic use (hypothesized to be reduced) and overall complication rates (hypothesized to remain unchanged). Given there are no published data on the efficacy and safety of using Exparel™ in open gynecologic abdominal surgery, this will be a pilot study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bupivacaine HCl in TAP block
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.
Bupivacaine
bupivacaine hydrochloride used in TAP block
Liposomal Bupivicaine in TAP block
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.
liposomal bupivacaine
liposomal bupivacaine used in TAP block
Interventions
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Bupivacaine
bupivacaine hydrochloride used in TAP block
liposomal bupivacaine
liposomal bupivacaine used in TAP block
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Consent for TAP block signed by patients preoperatively by anesthesiology
Exclusion Criteria
* All patients under 18 years of age
* minimally invasive surgery such as laparoscopy or robotic assisted laparoscopy
* medical contraindications to use of bupivacaine or liposomal bupivacaine such as severe hepatic and/or renal disease
18 Years
99 Years
FEMALE
Yes
Sponsors
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Abington Memorial Hospital
OTHER
Responsible Party
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Heidi Ching, MD
OBGYN Resident Physician
Principal Investigators
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Heidi Ching, MD
Role: PRINCIPAL_INVESTIGATOR
OB GYN Resident
Locations
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Abington Hospital Jefferson Health
Abington, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Mark Shahin, MD
Role: primary
Heidi Ching, MD
Role: backup
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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FWA00004123
Identifier Type: -
Identifier Source: org_study_id