Phase 4
Completed N=101
Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)
Pain, Postoperative · Crohn Disease · Inflammatory Bowel Disease · Colorectal Cancer
Source: ClinicalTrials.gov NCT03723447 ↗
Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent) — 47; 69 Oral morphine equivalents
◆ Published Evidence
Established
25citations · ~5 / year
A Prospective Randomized Trial of Surgeon-Administered Intraoperative Transversus Abdominis Plane Block With Bupivacaine Against Liposomal Bupivacaine: The TINGLE 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. 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.
Linked Publications
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A Prospective Randomized Trial of Surgeon-Administered Intraoperative Transversus Abdominis Plane Block With Bupivacaine Against Liposomal Bupivacaine: The TINGLE Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent) |
47; 69 | — |
| SECONDARY Post-op Pain Score (Visual Analog Scale) |
4; 4 | — |
| SECONDARY Bowel Motility |
1; 1 | — |
| SECONDARY Postoperative Length of Stay |
3; 3 | — |
| SECONDARY Postoperative Complications |
29; 32; 7; 2; 8; 7 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03723447) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.