Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)

Study Overview
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Brief Summary
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Traditionally, opioids are heavily utilized in treating postoperative pain but they are associated with numerous side effects. The use of the transversus abdominis plane (TAP) blocks have become standard practice to extend the post-operative analgesic window and limit opioid use. A new liposomal-depo formulation of bupivacaine (Exparel) has gained popularity as a long-lasting TAP block medication, but has not been studied in a well-powered clinical trial specifically in colorectal patients nor compared to a bupivacaine/steroid mixture which may offer similar effects. We conduct a prospective randomized prospective randomized study of patients undergoing major laparoscopic colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus liposomal bupivacaine.

Detailed Description
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Postoperative pain can pose significant challenges in the postoperative recovery of patients undergoing major colorectal surgery. Traditionally, opioids have played an important role in treating postoperative pain. It is well established that opioids are highly effective in relieving pain; however, opioids are associated with numerous side effects that include nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus, drowsiness, sedation, and allergic reaction. These opioid side effects, which range in severity, can significantly interfere with discharge home, particularly following colorectal surgery. Significant interest has grown for the use of guided regional anesthesia, specifically the use of the transversus abdominis plane (TAP) block to extend the post-operative analgesic window and ultimately limit opioid use. While bupivacaine formulations including a steroid has been shown to prolong the anesthetic effects of the regional field block, a new liposomal-depo formulation of bupivacaine (Exparel) has gained popularity and has additionally been shown to provide extended analgesia. Although promising data exists surrounding each modality, liposomal bupivacaine has not been studied in a well-powered clinical trial specifically in colorectal patients nor compared to a bupivacaine/steroid mixture. We are proposing a prospective randomized study of patients undergoing major laparoscopic colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus liposomal bupivacaine (Exparel). We hypothesize that the liposomal formulation of bupivacaine will provide superior perioperative pain control at 48 hours post-operation measured by total consumed oral morphine equivalents. In addition, we will measure postoperative pain scores, time until ambulation, antiemetic use, length of postoperative hospital stay, postoperative ileus, and adverse events directly related or unrelated to TAP block in the 30-day postoperative period between the three groups.

Official Title
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A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial

Conditions
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Pain, Postoperative, Crohn Disease, Inflammatory Bowel Diseases, Colorectal Cancer, Gastrointestinal Cancer, Gastrointestinal Disease, Digestive System Disease, Pain, Pain, Neuropathic, Intestinal Disease

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine/epinephrine/dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female Undergoing major laparoscopic colorectal procedure Willingness and ability to sign an informed consent document No allergies to anesthetic or analgesic medications ASA physical status Class I - III Aged 18-90 years Exclusion Criteria: Refusal to participate in the study Age <18 or > 90 years Pregnancy Contraindications to regional anesthetic including but not limited to: Patient refusal to regional field blockade Allergy Infection at the site of needle insertion Systemic infection Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory evaluation) Liver or renal disease (SCr > 1.5) Chronic opioid use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine/epinephrine/dexamethasone TAP block<br>For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered. | Drug: Bupivacaine/epinephrine/dexamethasone<br>* Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.<br>* Other names: Decadron;|
| Active Comparator: Liposomal bupivacaine TAP block<br>For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered. | Drug: Liposomal bupivacaine<br>* Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.<br>* Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent) |  | 48-hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-op Pain Score (Visual Analog Scale) | Visual pain scale recordings will be totaled and averaged during the first 72-hours post-surgery. Visual analog scale is determined by nursing staff when assessing pain scores. Scores range from 0-10 with 10 being the most pain. These values are typically interpreted by nursing staff as mild, moderate, or severe pain and pain medication is given accordingly. | 72-hours post-surgery | 
| Bowel Motility | Time till first bowel movement | 72 hours post-surgery | 
| Postoperative Length of Stay | Time from operation until hospital discharge | 30 days post-surgery | 
| Postoperative Complications | Medical or surgical complications measured by Clavien-Dindo classification Clavien-Dindo grade I: any deviation from normal postoperative course no pharmacological or surgical treatment, endoscopic, or radiological interventions were required. Acceptable therapeutic regiments are drugs such as anti-emetics, antipyretics, analgesics, diuretics, and electrolytes. Wound infections or small abscess requiring incision at bedside is within this category Clavien-Dindo grade II: Normal course altered Pharacological management other than in grade 1. Blood transfusions and total parenteral nutrition are also included. Clavien-Dindo grade III: complications that require intervention of various degrees management of these complications require an intervention under local anesthesia or general or epidural anesthesia Clavien-Dindo grade IV: complications threatening the life of a patient manifesting in organ dysfunction, including dialysis | 30 days post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone, pain, transversus abdominis plane block, tap block, liposomal bupivacaine, exparel, colorectal surgery, regional anesthesia, bupivacaine, surgery, postoperative pain