Recruiting

Liposomal Bupivacaine & Bupivacaine

Sponsor:

Hartford Hospital

Code:

NCT05224089

Conditions

Bowel Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liposomal Bupivicaine/Bupivacaine Admixture

Bupivacaine HCL

Study Details

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.

Conditions

Bowel Disease

Study ID

NCT05224089

Start date

Apr 27, 2022

Status verified date

Mar, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Liposomal Bupivacaine/Bupivacaine HCL

20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.

active comparator: Regular Bupivacaine Arm

80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL of normal saline. Total 100mL divided into 10mL syringes, 30mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.

Interventions

Liposomal Bupivicaine/Bupivacaine Admixture

60mL of 0.25% Bupivacaine (150mg)+ 20 mL of 1.3% Exparel (266 mg)+20mL NS=100mL

Bupivacaine HCL

80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL NS= 100mL

Primary outcome measure

  • The highest Numerical Pain Scores [ Time Frame: 3 days ]

Central Contacts and Locations

Central contacts

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Kevin J Finkel, MD

kevin.finkel@hhchealth.org

More Information

Sponsor

Hartford Hospital

Last update posted

Apr 2, 2025

Last verified

Mar, 2025

Keywords

  • Liposomal Bupivacaine
  • Exparel
  • Bupivacaine
  • Laparoscopic Colectomy
  • Transverse Abdominis Plane Blocks (TAP)
  • Regional anesthesia
  • Rectus Sheath Block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2025-04-02.