Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

Study Overview
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Brief Summary
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The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.

Detailed Description
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Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects. Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively). In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.

Official Title
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TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial

Conditions
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Opioid Use, Pain, Postoperative, Colectomy, Colorectal Surgery

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Bupivacaine liposome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery Exclusion Criteria: Allergic to local anesthetics Unable to provide consent Pregnant On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study) Undergoing emergent operations Undergoing loop ileostomy reversal Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Bupivacaine<br>Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. | Drug: Bupivacaine<br>* Abdominal injection of bupivacaine into fascial layer.<br>* Other names: Marcaine;|
| Experimental: Bupivacaine Liposome<br>Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. | Drug: Bupivacaine liposome<br>* Abdominal injection of bupivacaine liposome into fascial layer.<br>* Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital Postoperative Opioid Consumption | Daily overall opioid use recorded as morphine equivalents | up to postoperative day 3 at 1 pm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Recorded on a scale of 0 (No pain) to 10 (Worst possible pain) | Approximately every 6 hours through postoperative day 3 by 1 pm | 
| Time to Patient Mobilization | Number of days from day of surgery until patient mobilization | From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery). | 
| Time to Return of Bowel Function | Number of days from time of surgery until return of bowel function | From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery). | 
| Time to Clear Liquid Diet | Number of days from time of surgery until patient tolerates clear liquid diet | From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery). | 
| Time to Low Fiber Diet | Number of days from day of surgery until patient tolerates low fiber diet | From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery). | 
| Length of Stay | Total postoperative hospital stay in days | Date of surgery to date of discharge (usually up to 4 days after surgery). | 
| In-hospital Antiemetic Use | Amount of ondansetron patient required postoperatively during hospital stay, in milligrams | Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery). | 
| Complications | Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery | Within 30 days of surgery | 
| Readmissions | Patient readmitted to hospital after discharge | Within 30 days of hospital discharge | 
| Mortality | Patient death after surgery | Within 30 days of surgery | 
| Hospitalization Costs | Total hospitalization costs per patient per this surgical encounter | From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Exparel, TAP Block, Opioids, Narcotics, ERAS