Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07577934

Liposomal Bupivacaine Versus Ropivacaine for Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Randomized, Single-Blind, Parallel-Group Trial

Led by Tianjin First Central Hospital · Updated on 2026-05-14

86

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the pain relief effectiveness of liposomal bupivacaine compared to ropivacaine when used for transversus abdominis plane (TAP) block in patients undergoing laparoscopic gallbladder removal surgery. This randomized, single-blind, parallel-group clinical trial focuses on improving postoperative pain management. The primary measure is the dynamic pain score 24 hours after surgery, with additional assessments of recovery quality, analgesic use, and complications over time. Participants will be randomly assigned to receive either liposomal bupivacaine or standard-dose ropivacaine administered via ultrasound-guided TAP block after surgery. Both groups will receive routine clinical care during their hospital stay. The study includes follow-up assessments up to three months after surgery to monitor the development of chronic post-surgical pain. During the study, participants will have their pain levels measured at 24, 48, and 72 hours after surgery, along with evaluations of recovery quality using the QoR-15 scale. Researchers will track the time until additional pain medication is needed, total pain medication used, gastrointestinal recovery, hospital stay length, and any adverse events. Follow-up visits will assess longer-term pain outcomes, with the entire study lasting up to three months after surgery.

CONDITIONS

Brief Title

Efficacy of Liposomal Bupivacaine for Transversus Abdominis Plane Block

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years, any gender
  • Scheduled for elective laparoscopic cholecystectomy
  • ASA physical status I to III
  • Able to provide written informed consent and complete 3-month follow-up
Not Eligible

You will not qualify if you...

  • Allergy to local anesthetics
  • History of dementia, psychosis, or other central nervous system diseases
  • History of chronic pain or long-term opioid or analgesic use
  • Contraindications to nerve block such as infection at puncture site or severe coagulopathy
  • Severe liver or kidney dysfunction, pregnancy, or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo laparoscopic cholecystectomy followed by a transversus abdominis plane (TAP) block with either liposomal bupivacaine or ropivacaine.

1 visit (in-person)

Post-operative Follow-up

Duration - Up to 7 days after surgery

Participants are monitored for pain, recovery quality, analgesic use, gastrointestinal function, and adverse events after surgery.

Visits at 24, 48, and 72 hours after surgery, and daily assessments through hospital discharge

Trial Site Locations

Total: 1 location

1

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China, 300384

Actively Recruiting

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Research Team

K

Ke yu Zhang

L

Lili Jia

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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