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

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ClinicalTrials.gov Identifier: NCT03723447
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Karen Zaghiyan, Cedars-Sinai Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Crohn Disease Inflammatory Bowel Diseases Colorectal Cancer Gastrointestinal Cancer Gastrointestinal Disease Digestive System Disease Pain Pain, Neuropathic Intestinal Disease Drug: Liposomal bupivacaine Drug: Bupivacaine/epinephrine/dexamethasone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


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 Name: 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 Name: Exparel




Primary Outcome Measures :
  1. Narcotic usage [ Time Frame: 72 hours post-surgery ]
    All narcotics used during the first 72 hours post-surgery periods will be converted to oral morphine equivalents and totaled


Secondary Outcome Measures :
  1. Post-op Pain [ Time Frame: 72 hours post-surgery ]
    Visual pain scale recordings will be totaled and averaged during the first 72 hours post-surgery

  2. Bowel motility [ Time Frame: 72 hours post-surgery ]
    Time till flatus/ bowel movement

  3. Hospital length of stay [ Time Frame: 30 days post-surgery ]
    Time from operation until hospital discharge

  4. Adverse events [ Time Frame: 30 days post-surgery ]
    Medical or surgical complications measured by Clavien-Dindo classification



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723447


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
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Responsible Party: Karen Zaghiyan, Surgeon Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03723447    
Other Study ID Numbers: Pro00053363
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Karen Zaghiyan, Cedars-Sinai Medical Center:
transversus abdominis plane block
tap block
liposomal bupivacaine
exparel
dexamethasone
colorectal surgery
regional anesthesia
bupivacaine
surgery
postoperative pain
pain
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neuralgia
Pain, Postoperative
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Gastroenteritis
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Dexamethasone
Epinephrine
Bupivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones