Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07271979

Liposomal Bupivacaine Versus Ropivacaine for Preperitoneal Infiltration Analgesia in Upper Abdominal Laparotomy: A Randomized Double-Blind Controlled Trial

Led by Qilu Hospital of Shandong University · Updated on 2026-02-27

146

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 and anti-inflammatory effects of two local anesthetic drugs, liposomal bupivacaine and ropivacaine, in patients undergoing upper abdominal open surgery. This trial focuses on managing postoperative pain, which is often moderate to severe and can delay recovery and reduce quality of life. The study aims to see how these drugs, administered before closing the abdomen, compare in controlling pain and inflammation after surgery. Participants are randomly assigned to receive either liposomal bupivacaine or ropivacaine injected into the preperitoneal space along the surgical incision before the abdomen is closed. Liposomal bupivacaine is a newer, long-acting formulation designed to release medication over 48 to 72 hours, while ropivacaine is a standard local anesthetic. Both groups follow the same anesthesia and postoperative pain management protocols apart from the local anesthetic injection. During the study, participants will be closely monitored with pain scores recorded on the first day after surgery and other measures tracked over the first three days, including opioid use, sleep quality, recovery scales, and inflammation markers like C-reactive protein. Researchers will also observe complications and hospital stay length. Follow-up will assess postoperative complications up to one month after surgery, providing a comprehensive evaluation of each drug's clinical value in pain control.

CONDITIONS

Brief Title

Liposomal Bupivacaine Versus Ropivacaine for Preperitoneal Infiltration Analgesia in Upper Abdominal Laparotomy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years; for those over 70 years old, a Karnofsky Performance Status score of 80 or higher is required
  • Scheduled for elective upper abdominal laparotomy
  • Surgical approach involves either a subcostal or midline incision
  • Incision length between 15 and 30 centimeters
  • American Society of Anesthesiologists (ASA) physical status classification of I to III
Not Eligible

You will not qualify if you...

  • ASA physical status classification greater than III
  • Pre-existing chronic pain with long-term opioid use for more than 1 year
  • Significant liver or kidney problems, including estimated glomerular filtration rate below 40 mL/min/1.73m², Child-Pugh Class C, or body mass index under 18.5 kg/m²
  • Known allergy or hypersensitivity to the study drug or its ingredients
  • 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.

1 visit (in-person)

Treatment

Duration - Surgery day plus up to 3 postoperative days

Participants undergo upper abdominal laparotomy surgery during which they receive preperitoneal injections of either liposomal bupivacaine or ropivacaine for postoperative pain management.

1 surgery day visit and daily visits for up to 3 days post-surgery

Follow-up

Duration - Up to 1 month after surgery

Participants are monitored for postoperative complications and recovery outcomes after hospital discharge, including assessments up to one month after surgery.

1 follow-up visit approximately 1 month after surgery

Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, China

Actively Recruiting

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Research Team

J

Jinying Zhang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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