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Pain, PostoperativePhase 4TINGLENCT03723447

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

A Phase 4 study testing Liposomal bupivacaine and Bupivacaine/epinephrine/dexamethasone in people with Pain, Postoperative and Crohn Disease, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Liposomal bupivacaine and Bupivacaine/epinephrine/dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteUnited States
Study dates
23 Oct 2018to 29 Oct 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Liposomal bupivacaine, Bupivacaine/epinephrine/dexamethasone
Keywords
transversus abdominis plane block, tap block, liposomal bupivacaine, exparel, dexamethasone, colorectal surgery, regional anesthesia, bupivacaine, surgery, postoperative pain, pain
Medical subject headings
Pain, Postoperative, Crohn Disease, Inflammatory Bowel Diseases, Colorectal Neoplasms, Gastrointestinal Neoplasms, Gastrointestinal Diseases, Digestive System Diseases, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal bupivacaineDrug

    Also called Exparel

    Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.

  • Bupivacaine/epinephrine/dexamethasoneDrug

    Also called Decadron

    Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.

Study groups in NCT03723447
Study groupRoleWhat they receive
Bupivacaine/epinephrine/dexamethasone TAP blockActive comparatorFor the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
Receives: Drug: Bupivacaine/epinephrine/dexamethasone
Liposomal bupivacaine TAP blockActive comparatorFor the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Receives: Drug: Liposomal bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 48-hours

Secondary outcomes (4)

  1. 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.

    Measured: 72-hours post-surgery

  2. Bowel Motility

    Time till first bowel movement

    Measured: 72 hours post-surgery

  3. Postoperative Length of Stay

    Time from operation until hospital discharge

    Measured: 30 days post-surgery

  4. 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

    Measured: 30 days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2018
  2. Study start23 Oct 2018
  3. Primary completion29 Oct 2019
  4. Study completion29 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03723447
Sponsor's protocol ID
Pro00053363
Acronym
TINGLE
Status last verified
Feb 2021
First submitted
26 Oct 2018
Last updated
17 Feb 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31515761

  • 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.

    PubMed 31657314

  • 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.

    PubMed 27505115

  • 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.

    PubMed 34086002

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liposomal bupivacaine and Bupivacaine/epinephrine/dexamethasone in people with Pain, Postoperative and Crohn Disease, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent) (time frame: 48-hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03723447, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.

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