Clinical trial · Interventional
Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)
A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Crohn Disease | — | UNRESOLVED | — |
| Digestive System Disease | — | UNRESOLVED | — |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Gastrointestinal Disease | — | UNRESOLVED | — |
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
| Intestinal Disease | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Pain, Neuropathic | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine/epinephrine/dexamethasone | Drug | — | UNRESOLVED |
| Liposomal bupivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bupivacaine/epinephrine/dexamethasone TAP block
- description
- For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
- interventionNames
- Drug: Bupivacaine/epinephrine/dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- Liposomal bupivacaine TAP block
- description
- For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
- interventionNames
- Drug: Liposomal bupivacaine
Primary outcomes (1)
- measure
- Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDMujukian 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. PMID 31515761
- BACKGROUNDTruong 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. PMID 31657314
- BACKGROUNDKnudson 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. PMID 27505115
- DERIVEDTruong 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. PMID 34086002