The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.
All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
0.25% bupivacaine for TAP block
Exparel for TAP block
Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
Henry Ford Hospital
Detroit, Michigan, United States
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
Total opioid consumption
Time frame: 0 - 72 hours post-operatively
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given
time to first opioid given
Time frame: 0 - 72 hours post-operatively
Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied
Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.
Time frame: 0 - 72 hours post-operatively
Length of Stay in the Hospital
Length of stay in the hospital, maximum time until discharge from the hospital
Time frame: until the patient is discharged from the hospital
Number of Patients With Local Anesthetic Toxicity
Presence of local anesthetic toxicity
Time frame: 0 - 72 hours post-operatively
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure
Presence of hemodynamic instability
Time frame: 0 - 72 hours post-operatively
Pain Scores Using Visual Analogue Scale ( 0-10)
Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.
Time frame: 0-24 postoperative pain scores
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