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

Primary Purpose

Pain, Postoperative, Crohn Disease, Inflammatory Bowel Diseases

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine/epinephrine/dexamethasone
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring transversus abdominis plane block, tap block, liposomal bupivacaine, exparel, dexamethasone, colorectal surgery, regional anesthesia, bupivacaine, surgery, postoperative pain, pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bupivacaine/epinephrine/dexamethasone TAP block

Liposomal bupivacaine TAP block

Arm Description

For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.

For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.

Outcomes

Primary Outcome Measures

Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)

Secondary Outcome Measures

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.
Bowel Motility
Time till first bowel movement
Postoperative Length of Stay
Time from operation until hospital discharge
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

Full Information

First Posted
October 26, 2018
Last Updated
February 8, 2021
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03723447
Brief Title
Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)
Acronym
TINGLE
Official Title
A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
October 29, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Crohn Disease, Inflammatory Bowel Diseases, Colorectal Cancer, Gastrointestinal Cancer, Gastrointestinal Disease, Digestive System Disease, Pain, Pain, Neuropathic, Intestinal Disease
Keywords
transversus abdominis plane block, tap block, liposomal bupivacaine, exparel, dexamethasone, colorectal surgery, regional anesthesia, bupivacaine, surgery, postoperative pain, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine/epinephrine/dexamethasone TAP block
Arm Type
Active Comparator
Arm Description
For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
Arm Title
Liposomal bupivacaine TAP block
Arm Type
Active Comparator
Arm Description
For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine/epinephrine/dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
Primary Outcome Measure Information:
Title
Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)
Time Frame
48-hours
Secondary Outcome Measure Information:
Title
Post-op Pain Score (Visual Analog Scale)
Description
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.
Time Frame
72-hours post-surgery
Title
Bowel Motility
Description
Time till first bowel movement
Time Frame
72 hours post-surgery
Title
Postoperative Length of Stay
Description
Time from operation until hospital discharge
Time Frame
30 days post-surgery
Title
Postoperative Complications
Description
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
Time Frame
30 days post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Zaghiyan, MD
Organizational Affiliation
Cedars Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31515761
Citation
Mujukian A, Truong A, Tran H, Shane R, Fleshner P, Zaghiyan K. A Standardized Multimodal Analgesia Protocol Reduces Perioperative Opioid Use in Minimally Invasive Colorectal Surgery. J Gastrointest Surg. 2020 Oct;24(10):2286-2294. doi: 10.1007/s11605-019-04385-9. Epub 2019 Sep 12.
Results Reference
background
PubMed Identifier
31657314
Citation
Truong A, Mujukian A, Fleshner P, Zaghiyan K. No Pain, More Gain: Reduced Postoperative Opioid Consumption with a Standardized Opioid-Sparing Multimodal Analgesia Protocol in Opioid-Tolerant Patients Undergoing Colorectal Surgery. Am Surg. 2019 Oct 1;85(10):1155-1158.
Results Reference
background
PubMed Identifier
27505115
Citation
Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.
Results Reference
background
PubMed Identifier
34086002
Citation
Truong A, Fleshner PR, Mirocha JM, Tran HP, Shane R, Zaghiyan KN. A Prospective Randomized Trial of Surgeon-Administered Intraoperative Transversus Abdominis Plane Block With Bupivacaine Against Liposomal Bupivacaine: The TINGLE Trial. Dis Colon Rectum. 2021 Jul 1;64(7):888-898. doi: 10.1097/DCR.0000000000002008.
Results Reference
derived

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

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