Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
ID07458282

The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Transversus Abdominis Plane Block for Postoperative Pain in Patients Undergoing Laparoscopic Surgery: A Multi-Center Randomized Controlled Trial

Led by Beijing Tiantan Hospital · Updated on 2026-03-17

318

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Laparoscopic surgery is commonly chosen for abdominal procedures because it is less invasive, allows quicker recovery, and has fewer complications. However, many patients still experience postoperative pain, which can delay recovery and may develop into chronic pain without proper management. While opioids are effective for pain relief, their side effects limit their use after minimally invasive surgeries. This research evaluates the use of ultrasound-guided transversus abdominis plane block (TAPB) with liposomal bupivacaine, a longer-acting local anesthetic, to improve pain control after laparoscopic surgery. The study compares two groups of patients undergoing laparoscopic surgery. One group receives a TAPB using bupivacaine hydrochloride, while the other group receives a TAPB with a combination of liposomal bupivacaine and bupivacaine. Both groups receive patient-controlled analgesia pumps with sufentanil and ondansetron postoperatively. Additional pain medications like oxycodone-acetaminophen tablets or intravenous morphine may be given if needed. The injections are performed before the surgical incision using ultrasound guidance. Participants will be monitored for pain levels at rest and during movement at multiple time points up to three months after surgery. Researchers will track the use of rescue pain medications, patient satisfaction, sedation levels, recovery quality, and any side effects or complications. Other assessments include length of hospital stay and total costs. The primary outcome is the amount of intravenous morphine equivalents used within 48 hours after surgery. The study aims to provide detailed information about pain relief effectiveness and safety of liposomal bupivacaine in laparoscopic surgery patients.

CONDITIONS

Brief Title

The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective laparoscopic cholecystectomy, hernia repair, and appendectomy under general anesthesia
  • Age between 18 and 64 years old
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Glasgow Coma Scale (GCS) score of 15
  • Ability to understand the clinical trial and provide informed consent
Not Eligible

You will not qualify if you...

  • History of chronic pain syndrome
  • Heart conduction block (sinus or atrioventricular block)
  • Unstable coronary artery disease
  • Gastric ulcer or gastric bleeding
  • Diabetes treated with insulin
  • Coagulation dysfunction or use of oral anticoagulants not stopped before surgery
  • Abnormal liver function (ALT/AST > 2x upper limit or bilirubin ≥ 1.5x upper limit)
  • Renal impairment or recent dialysis
  • Diagnosed mental illness or current psychotropic medication use
  • Excessive alcohol or drug abuse, chronic opioid use, or recent use of sedative/analgesic drugs
  • Pregnancy or breastfeeding
  • Extreme body mass index (<15 or >35)
  • Participation in another interventional trial interfering with this study
  • History of allergy to local anesthetics or study drugs

AI-Screening

AI-Powered Screening

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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 - Up to 48 hours postoperatively

Participants undergo laparoscopic surgery with a transverse abdominis plane block using either liposomal bupivacaine plus bupivacaine or bupivacaine hydrochloride to manage postoperative pain. Postoperative pain is managed with patient-controlled analgesia and additional medications as needed.

1 surgical visit and postoperative monitoring up to 48 hours

Follow-up

Duration - 3 months

Participants are followed for additional assessments of pain, recovery, and any adverse events up to 3 months after surgery.

Visits at 1 week, 1 month, and 3 months postoperatively

Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

F

Fang Luo

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Comparison of ultrasound-guided bilateral subcostal transversus abdominis plane block and port-site infiltration with bupivacaine in laparoscopic cholecystectomy.

Indu Suseela, Krishnadas Anandan, Arun Aravind...

https://pubmed.ncbi.nlm.nih.gov/30078851

Pain management after laparoscopic appendectomy: Comparative effectiveness of innovative pre-emptive analgesia using liposomal bupivacaine.

Anthony C Waddimba, Pete Newman, Jordin K Shelley...

https://pubmed.ncbi.nlm.nih.gov/34610868