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

February 8, 2021 updated by: Karen Zaghiyan, Cedars-Sinai Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bupivacaine/epinephrine/dexamethasone TAP block
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
Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
Other Names:
  • Decadron
ACTIVE_COMPARATOR: Liposomal bupivacaine TAP block
For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Drug: Liposomal bupivacaine
Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Karen Zaghiyan, MD, Cedars Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 23, 2018

Primary Completion (ACTUAL)

October 29, 2019

Study Completion (ACTUAL)

October 29, 2019

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

October 26, 2018

First Posted (ACTUAL)

October 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00053363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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