Comparing two types of pain relief for laparoscopic colectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hartford Hospital
  Hartford, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Kevin Finkel, MD — Hartford Hospital
• Study coordinator: Aseel Walker, MD
• Email: aseel.walker@hhchealth.org
• Phone: 860-972-1778

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving capsule endoscopy diagnostics with artificial intelligence

  This study is testing whether using artificial intelligence can help doctors read capsule endoscopy images more accurately and quickly for patients getting this routine procedure.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT06152289

• Treatment with Subcutaneous Infliximab for Crohn's Disease

  This study is testing if a new way of giving infliximab can help people with moderate to severe Crohn's disease feel better without needing steroids.

  Recruiting Phase 3 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam, North Holland · NCT06059989

• Creating a tool to improve CT imaging decisions for blunt trauma patients

  This study is testing a new tool to help doctors decide when CT scans are really needed for patients with blunt trauma to avoid unnecessary radiation and costs.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT04937868

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.