Surgical Site Infiltration of Exparel vs TAP Block With Exparel in Patients Undergoing Laparotomy Via Midline Incision

Study Overview
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Brief Summary
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This is a randomized-controlled prospective study to be conducted at Danbury Hospital and Norwalk Hospital to compare postoperative opioid consumption and pain scores of patients with suspected or known gynecologic malignancies undergoing midline laparotomy who received TAP block with liposomal bupivacaine versus surgical site infiltration of liposomal bupivacaine. Primary outcome: Total postoperative opioid consumption as measured by morphine equivalents over 48 hour period. Secondary outcomes include: Pain scores (based on visual analog scale 1-10) at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively at rest and upon exertion (Valsalva maneuver), Severity of nausea, Episodes of vomiting, Total antiemetics consumption over 48 hour period.

Detailed Description
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Recent studies suggest surgical site infiltration of local anesthetic into the preperitoneal, subfascial and/or subcutaneous planes as an alternative approach. The literature suggests this offers superior pain relief and significantly reduced morphine consumption. This procedure has been shown to provide excellent analgesia in open inguinal hernia repair and colorectal procedures up to 72 hours after a single injection. However, there is limited published data comparing TAP block with liposomal bupivacaine and surgical site infiltration of liposomal bupivacaine in open hysterectomy patients. The investigators propose to prospectively study the efficacy of surgical site infiltration of liposomal bupivacaine versus TAP block with liposomal bupivacaine in patients with suspected or known gynecologic malignancies undergoing midline laparotomy. The investigators hypothesize that surgical site infiltration of liposomal bupivacaine is more effective than TAP block with liposomal bupivacaine in this patient population. The investigators primary outcome will be postoperative total 48 hour opioid consumption. Secondary outcomes will include visual analog scale (VAS) pain scores at rest and upon exertion (Valsalva maneuver) at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively, severity of nausea, episodes of vomiting and total antiemetics consumption postoperatively. Pain scores and severity of nausea scores will be collected in person or over the phone. The investigators expect the results of this study to demonstrate that surgical site infiltration of liposomal bupivacaine in patients with suspected or known gynecologic malignancies undergoing midline laparotomy may help shorten the recovery period and reduce the need for postoperative opioid medications. Furthermore, generally patients undergoing procedures such as tumor debulking and lymph node dissection would have an extended hospitalization. If surgical site infiltration of liposomal bupivacaine administration is found to decrease the length of hospitalization (versus TAP Block with liposomal bupivacaine), it will significantly decrease the health care costs.

Official Title
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Surgical Site Infiltration of Liposomal Bupivacaine Versus Transversus Plane Block With Liposomal Bupivacaine in Patients With Suspected or Known Gynecologic Cancer Undergoing Laparotomy Via Midline Incision

Conditions
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Postoperative Pain, Postoperative Nausea and Vomiting, Opioid Use

Intervention / Treatment
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* Procedure: TAP Block
* Procedure: Surgical Site Infiltration
* Drug: Exparel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any woman age 18 or over with known or suspected gynecologic malignancy who is scheduled for laparotomy via vertical midline incision at Danbury Hospital or Norwalk Hospital American Society of Anesthesiologists physical status I to IV (a normal healthy patient to a patient with severe systemic disease that may be constant threat to life) English or Spanish speaking Exclusion Criteria: Pregnancy Unable to obtain consent Severe allergies and/or anaphylaxis to bupivacaine or other anesthetics of the same class, to hydromorphone or morphine equivalents Patients taking fospropofol, hyaluronidase, propofol, propranolol, St John's Wort and verapamil at the time of screening Significant psychiatric disturbance as recorded in the medical record Current or history of alcohol or drug addiction Have current acute or chronic pain disorders as indicated in medical record Current or history of opioid dependence Contraindications to acetaminophen (significant hepatic dysfunction or disease), ketorolac and ibuprofen (significant renal dysfunction or reactive airway disease) ≥2 previous midline laparotomies BMI >45

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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Accepts Healthy Volunteers

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 randomized to TAP block with liposomal bupivacaine OR surgical site infiltration of liposomal bupivacaine for postoperative analgesia after undergoing midline laparotomy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP block with Exparel<br>Patients will receive immediate postoperative bilateral 2-quadrant TAP block with Exparel (liposomal bupivacaine) admixed with bupivacaine HCl and saline by the anesthesia team. | Procedure: TAP Block<br>* Transversus Plane block<br>Drug: Exparel<br>* liposomal bupivacaine<br>|
| Active Comparator: Surgical Site Infiltration of Exparel<br>Patients will receive surgical site infiltration of Exparel (liposomal bupivacaine) admixed with bupivacaine HCl and saline by surgeon. | Procedure: Surgical Site Infiltration<br>* Surgical Site Infiltration<br>Drug: Exparel<br>* liposomal bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative opioid consumption over 48 hours | Total postoperative opioid consumption as measured by morphine milligram equivalents (MME) | over 48 hour period after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores at rest and upon exertion | Pain scores based on Wong-baker FACES Pain Rating Scale (Visual analog scale (VAS)) at rest and upon exertion (Valsalva maneuver) will be collected in person or over the phone. 0 - no hurt, 2 - hurts little bit, 4 - hurts little more, 6 - hurts even more, 8 - hurts whole lot, 10 - hurts worst. | 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively | 
| Severity of nausea | Severity of nausea will be collected in person or over the phone. Severity of Nausea Scale:- 0 = none, 1 = mild, 2 = moderate, 3 = severe | 2, 6, 12, 24, & 48 hours postoperatively | 
| Episodes of vomiting | Total number of vomiting episodes will be collected from medical record. | 48 hours postoperatively | 
| Total antiemetics consumption | Total antiemetics consumption (type of antiemetic, mode of administration, dose, time of administration) will be collected from medical record. | 48 hour postoperatively |