Comparing two types of pain relief for laparoscopic colectomy

Bilateral Mid-Abdominal Transverse Abdominis Plane and Rectus Sheath Blocks Comparing The Use of Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy Procedures.

This study is testing if a new type of pain relief called liposomal bupivacaine works better than regular bupivacaine for patients having laparoscopic colectomy surgery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hartford Hospital (other)
• Locations: 1 site (Hartford, Connecticut)
• Trial ID: NCT05224089 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of liposomal bupivacaine compared to regular bupivacaine in providing pain relief through bilateral transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy. It is a single-center, prospective, triple-blinded randomized controlled study involving patients scheduled for elective surgery. The goal is to determine if the liposomal formulation offers superior pain management outcomes. The study will involve a comparison of pain levels and recovery metrics post-surgery.

Who should consider this trial

Good fit: Ideal candidates are English-speaking patients scheduled for elective laparoscopic colectomy with an ASA physical status score of I-IV.

Not a fit: Patients who may not benefit include those undergoing emergency surgeries, those with contraindications to TAP blocks, or those with certain medical conditions like coagulopathy.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management and recovery for patients undergoing laparoscopic colectomy.

How similar studies have performed: Previous studies have shown promising results with liposomal bupivacaine in various surgical settings, suggesting potential for success in this approach.

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

Where this trial is running

Hartford, Connecticut

• Hartford Hospital — Hartford, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Kevin Finkel, MD — Hartford Hospital
• Study coordinator: Aseel Walker, MD

Conditions: Bowel Disease, Liposomal Bupivacaine, Exparel, Bupivacaine, Laparoscopic Colectomy, Transverse Abdominis Plane Blocks, Regional anesthesia, Rectus Sheath Block