Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Morphine Equivalents at 72 Hours
Study Overview
Brief Summary
The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.
Detailed Description
After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The only people who will be unblinded are the members of the block team, who are not members of the care team nor the study team. They will open the envelopes, draw up the medications and cover the syringes with opaque paper such that no one can tell the contents.
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Not pregnant
- •Weight over 50kg presenting for open myomectomy
- •No history of allergy to any study medication
- •No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas
- •No history of drug or alcohol use or abuse disorder or pre-existing liver disease.
Exclusion Criteria
- Not provided
Arms & Interventions
Bupivacaine TAP
TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side
Intervention: Bupivacaine (Drug)
Bupivacaine TAP
TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side
Intervention: normal saline (Drug)
Liposomal bupivacaine TAP
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
Intervention: Bupivacaine (Drug)
Liposomal bupivacaine TAP
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
Intervention: Bupivacaine liposome (Drug)
Liposomal bupivacaine TAP
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
Intervention: normal saline (Drug)
Outcomes
Primary Outcomes
Morphine Equivalents at 72 Hours
Time Frame: 72 hours
Total cumulative opiates consumed converted to morphine equivalents
Secondary Outcomes
- Area under the curve pain scale at 96 hours(96 hours)
- Quality of Recovery at 48 hours(48 hours)
- Morphine Equivalents at 96 Hours(96 hours)
- Morphine Equivalents at 48 Hours(48 hours)
- Opiate Sparing Criteria at 72 hours(72 hours)
- Quality of Recovery at 72 hours(72 hours)
Investigators
Daniel Katz
Associate Professor
Icahn School of Medicine at Mount Sinai