Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Liposomal bupivacaine	Liposomal bupivacaine	Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine and bupivacaine	Liposomal bupivacaine	Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Liposomal bupivacaine	Saline	Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Bupivacaine	Bupivacaine	Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Liposomal bupivacaine and bupivacaine	Bupivacaine	Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine.

Primary Outcome Measures

Name	Time	Method
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)	0 - 72 hours post-operatively	Total opioid consumption
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given	0 - 72 hours post-operatively	time to first opioid given

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Local Anesthetic Toxicity	0 - 72 hours post-operatively	Presence of local anesthetic toxicity
Pain Scores Using Visual Analogue Scale ( 0-10)	0-24 postoperative pain scores	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.
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure	0 - 72 hours post-operatively	Presence of hemodynamic instability
Length of Stay in the Hospital	until the patient is discharged from the hospital	Length of stay in the hospital, maximum time until discharge from the hospital
Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied	0 - 72 hours post-operatively	Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.