NCT05224089 Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy
| NCT ID | NCT05224089 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hartford Hospital |
| Condition | Bowel Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2022-04-27 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 114 participants in total. It began in 2022-04-27 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will be a single center, prospective triple blinded randomized controlled study, comparing the use of liposomal bupivacaine (Exparel) to regular bupivacaine with adjuncts in bilateral mid-abdominal transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy procedures.
Eligibility Criteria
Inclusion Criteria: * Patients scheduled for elective laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study. * English speaking patients * Patients with American Society of Anesthesiology (ASA) physical status score I- IV Exclusion Criteria: 1. Emergency laparoscopic colectomy surgery 2. Patients with distant metastatic cancers (e.g. bone, lung, brain). 3. Scheduled for multi organs resection surgery in addition to colectomy. 4. Patients with contraindications to TAP or RS blocks including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral TAP blocks (e.g. surgical mesh at the site of TAP or RS block), or infection at the injection site. 5. Current colostomies. 6. History of allergy to local anesthetics. 7. Coagulopathy or coagulation disorder. Also patients who are receiving antithrombotic medications as a contraindication to receiving single shot peripheral nerve blockade as per the most recent American Society of Regional Anesthesiology (ASRA) guidelines.16 8. Weight \< 40 kg, as 40 mL of Bupivacaine 0.25%, or combination of 20 mL of bupivacaine 0.25% with 20 mL of liposomal bupivacaine is greater than the maximal dose allowed, given concern for local anesthetic toxicity. 9. Patients who take long acting opioid medication, or on continuous opioid \> 50 MME per day for at least 30 days within 90 days prior to surgery. Also patients who have chronic pain syndrome with a recent preoperative consultation to the chronic pain service. 10. Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs or excessive alcohol consumption as defined 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men.15 11. Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively 12. Refusal or lack of providing the study consent
Contact & Investigator
Kevin Finkel, MD
PRINCIPAL INVESTIGATOR
Hartford Hospital
Frequently Asked Questions
Who can join the NCT05224089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05224089 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05224089 currently recruiting?
Yes, NCT05224089 is actively recruiting participants. Contact the research team at aseel.walker@hhchealth.org for enrollment information.
Where is the NCT05224089 trial being conducted?
This trial is being conducted at Hartford, United States.
Who is sponsoring the NCT05224089 clinical trial?
NCT05224089 is sponsored by Hartford Hospital. The principal investigator is Kevin Finkel, MD at Hartford Hospital. The trial plans to enroll 114 participants.