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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hysterectomy

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Liposomal bupivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to one of three study groups.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine<br>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine | Drug: Bupivacaine<br>* 0.25% bupivacaine for TAP block<br>* Other names: Marcaine, Sensorcaine;|
| Active Comparator: Liposomal bupivacaine<br>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. | Drug: Liposomal bupivacaine<br>* Exparel for TAP block<br>* Other names: Exparel;Drug: Saline<br>* Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.<br>|
| Experimental: Liposomal bupivacaine and bupivacaine<br>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. | Drug: Bupivacaine<br>* 0.25% bupivacaine for TAP block<br>* Other names: Marcaine, Sensorcaine;Drug: Liposomal bupivacaine<br>* Exparel for TAP block<br>* Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) | Total opioid consumption | 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 | 0 - 72 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 - 72 hours post-operatively | 
| Length of Stay in the Hospital | Length of stay in the hospital, maximum time until discharge from the hospital | until the patient is discharged from the hospital | 
| Number of Patients With Local Anesthetic Toxicity | Presence of local anesthetic toxicity | 0 - 72 hours post-operatively | 
| Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure | Presence of hemodynamic instability | 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. | 0-24 postoperative pain scores | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAP block, Liposomal bupivicaine