Clinical trial NCT03250507: Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy
Official title: Mixture of Liposomal Bupivicaine and Bupivicaine Hydrogen Chloride (HCl) May Provide Faster and Longer Lasting Analgesia in Transversus Abdominis Block for Patient Having Open Abdominal Hysterectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hysterectomy
Keywords: TAP block
Liposomal bupivicaine
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to one of three study groups.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Elective open abdominal hysterectomy with midline incision, age \> 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.

Exclusion Criteria:

* Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.

Primary outcomes:
measure: Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
timeFrame: 0 - 72 hours post-operatively
measure: Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given
timeFrame: 0 - 72 hours post-operatively
Secondary outcomes:
measure: Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied
timeFrame: 0 - 72 hours post-operatively
measure: Length of Stay in the Hospital
timeFrame: until the patient is discharged from the hospital
measure: Number of Patients With Local Anesthetic Toxicity
timeFrame: 0 - 72 hours post-operatively
measure: Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure
timeFrame: 0 - 72 hours post-operatively
measure: Pain Scores Using Visual Analogue Scale ( 0-10)
timeFrame: 0-24 postoperative pain scores
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Mohamed-Rida Alsaden, MBChB FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fidkowski CW, Choksi N, Alsaden MR. A randomized-controlled trial comparing liposomal bupivacaine, plain bupivacaine, and the mixture of liposomal bupivacaine and plain bupivacaine in transversus abdominus plane block for postoperative analgesia for open abdominal hysterectomies. Can J Anaesth. 2021 Jun;68(6):773-781. doi: 10.1007/s12630-020-01911-1. Epub 2021 Jan 11.