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Liposomal Bupivacaine for Bowel Surgery Pain Management (TAPLIP Trial)

Q: How many volunteers are partaking in this research project?

Affirmative. Clinicaltrials.gov supports that the trial is currently recruiting, having first been posted on April 27th 2022 and updated most recently on June 30th 2022. It requires 114 volunteers at a single medical centre to complete it.

Q: Are researchers still taking participants for this clinical experiment?

As indicated on clinicaltrials.gov, this medical trial is seeking participants at the present moment. It was first posted in late April of 2022 and underwent its most recent update in June of that same year.

Q: To what extent is Bupivacaine HCL safe for patients to take?

Bupivacaine HCL has been approved for use, making it a safe option with an estimated score of 3.

Phase 4

Recruiting

Led By Kevin Finkel, MD

Research Sponsored by Hartford Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled for elective laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study

English speaking patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on the day of first postoperative visit, the end of the 6th and 12th postoperative months

Awards & highlights

TAPLIP Trial Summary

This trial will compare the use of a new painkiller, liposomal bupivacaine (Exparel), to regular bupivacaine with other painkillers in patients undergoing laparoscopic colectomy procedures.

Who is the study for?

This trial is for English-speaking patients scheduled for elective laparoscopic colectomy with an ASA score I-IV. Excluded are those with emergency surgery, metastatic cancers, planned multi-organ resection, TAP block contraindications like anatomical abnormalities or infection at the injection site, current colostomies, severe coagulation disorders, underweight (<40kg), chronic opioid use or substance abuse within 3 months.Check my eligibility

What is being tested?

The study compares liposomal bupivacaine (Exparel) to regular bupivacaine in bilateral mid-abdominal TAP blocks during laparoscopic colectomy. It's a single-center trial where participants are randomly assigned and triple-blinded to determine which medication provides better pain control.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site such as pain or infection, possible nerve damage from the block procedure itself, and systemic effects of local anesthetics like heart rhythm disturbances or central nervous system issues.

TAPLIP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific colon surgery by a study surgeon.

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I speak English.

TAPLIP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on the day of first postoperative visit, the end of the 6th and 12th postoperative months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on the day of first postoperative visit, the end of the 6th and 12th postoperative months

This trial's timeline: 3 weeks for screening, Varies for treatment, and on the day of first postoperative visit, the end of the 6th and 12th postoperative months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The highest Numerical Pain Scores

Secondary outcome measures

All pain scores, mild-moderate-severe.

Block complications

Brief Pain Inventory (Short Form)

+6 more

TAPLIP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Liposomal Bupivacaine/Bupivacaine HCLExperimental Treatment2 Interventions

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.

Group II: Regular Bupivacaine ArmActive Control1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor

133 Previous Clinical Trials

18,818 Total Patients Enrolled

Kevin Finkel, MDPrincipal InvestigatorHartford Hospital

2 Previous Clinical Trials

140 Total Patients Enrolled

Media Library

Bupivacaine HCL Clinical Trial Eligibility Overview. Trial Name: NCT05224089 — Phase 4

Bowel Diseases Research Study Groups: Liposomal Bupivacaine/Bupivacaine HCL, Regular Bupivacaine Arm

Bowel Diseases Clinical Trial 2023: Bupivacaine HCL Highlights & Side Effects. Trial Name: NCT05224089 — Phase 4

Bupivacaine HCL 2023 Treatment Timeline for Medical Study. Trial Name: NCT05224089 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are partaking in this research project?

"Affirmative. Clinicaltrials.gov supports that the trial is currently recruiting, having first been posted on April 27th 2022 and updated most recently on June 30th 2022. It requires 114 volunteers at a single medical centre to complete it."

Answered by AI

Are researchers still taking participants for this clinical experiment?

"As indicated on clinicaltrials.gov, this medical trial is seeking participants at the present moment. It was first posted in late April of 2022 and underwent its most recent update in June of that same year."

Answered by AI