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

Phase 4

Completed

• Conditions: Pain, Postoperative; Gastrointestinal Cancer; Pain; Colorectal Cancer; Inflammatory Bowel Diseases; Digestive System Disease; Gastrointestinal Disease; Intestinal Disease; Crohn Disease; Pain, Neuropathic
• Interventions: Drug: Liposomal bupivacaine; Drug: Bupivacaine/epinephrine/dexamethasone

• Registration Number: NCT03723447
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-10-23
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-10-26
• Study First Posted: 2018-10-29
• Primary Completion: 2019-10-29
• Study Completion: 2019-10-29
• Results First Submitted: 2020-12-16
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Results First Posted: 2021-02-17
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Male or Female
2. Undergoing major laparoscopic colorectal procedure
3. Willingness and ability to sign an informed consent document
4. No allergies to anesthetic or analgesic medications
5. ASA physical status Class I - III
6. Aged 18-90 years

Exclusion Criteria

1. Refusal to participate in the study

2. Age <18 or > 90 years

3. Pregnancy

4. Contraindications to regional anesthetic including but not limited to:

   1. Patient refusal to regional field blockade
   2. Allergy
   3. Infection at the site of needle insertion
   4. Systemic infection
   5. Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory evaluation)
   6. Liver or renal disease (SCr > 1.5)

5. Chronic opioid use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal bupivacaine TAP block	Liposomal bupivacaine	For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Bupivacaine/epinephrine/dexamethasone TAP block	Bupivacaine/epinephrine/dexamethasone	For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.

Primary Outcome Measures

Name	Time	Method
Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)	48-hours

Secondary Outcome Measures

Name	Time	Method
Post-op Pain Score (Visual Analog Scale)	72-hours post-surgery	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.
Bowel Motility	72 hours post-surgery	Time till first bowel movement
Postoperative Length of Stay	30 days post-surgery	Time from operation until hospital discharge
Postoperative Complications	30 days post-surgery	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

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States