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Recruiting NCT07577934

Efficacy of Liposomal Bupivacaine for Transversus Abdominis Plane Block

No phase Interventional Postoperative Pain Liposomal Bupivacaine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liposomal Bupivacaine TAP block, Ropivacaine TAP blocks.
Who it may be relevant to
Registry conditions: Postoperative Pain, Liposomal Bupivacaine. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

This is a single-center, randomized, single-blind, parallel-group clinical trial. The study aims to compare the analgesic efficacy of liposomal bupivacaine versus ropivacaine for transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. Eligible participants will be randomly assigned to receive either liposomal bupivacaine or ropivacaine for TAP block during surgery. The primary outcome is the dynamic NRS pain score at 24 hours after surgery. Secondary outcomes include static and dynamic NRS pain scores at multiple time points, QoR-15 recovery quality, time to first rescue analgesia, analgesic consumption, gastrointestinal function recovery, length of hospital stay, and adverse events. Participants will be followed up to 3 months after surgery to evaluate the incidence of chronic post-surgical pain (CPSP). All participants will receive routine clinical care, and participation is voluntary.

Interventions

  • Drug Liposomal Bupivacaine TAP block
    Liposomal bupivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.
  • Drug Ropivacaine TAP blocks
    Standard-dose ropivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.

Primary outcome measures

  • Postoperative dynamic NRS pain score at 24 hours [Time frame: 24 hours after surgery]
Secondary outcome measures (7)
  • Postoperative NRS pain scores at different time points [Time frame: 24, 48, and 72 hours after surgery]
  • Postoperative recovery quality (QoR-15 scale) [Time frame: 24, 48, and 72 hours after surgery]
  • Time to first rescue analgesia [Time frame: Up to 72 hours after surgery]
  • Total postoperative analgesic consumption within 72 hours [Time frame: 72 hours after surgery]
  • Gastrointestinal function recovery [Time frame: Postoperatively, through hospital discharge, up to 7 days after surgery]
  • Postoperative length of hospital stay [Time frame: Postoperatively, through hospital discharge (up to 7 days)]
  • Incidence of adverse events [Time frame: Postoperatively, through hospital discharge, and at follow-up (up to 7 days after surgery)]

Eligibility criteria

Inclusion criteria

  • Age 18-65 years, either gender.
  • Patients scheduled for elective laparoscopic cholecystectomy.
  • ASA physical status I-III.
  • Able to provide written informed consent and complete the 3-month follow-up.

Exclusion criteria

  • History of allergy to local anesthetics.
  • History of dementia, psychosis, or other central nervous system diseases.
  • History of chronic pain or long-term use of opioids or other analgesics.
  • Contraindications to nerve block: infection at puncture site, severe coagulopathy.
  • Severe hepatic or renal dysfunction, pregnancy, or lactation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin First Central Hospital — Tianjin

Identifiers

NCT: NCT07577934 · KYAP2025-52

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗