Using liposomal bupivacaine for pain relief after laparoscopic gynecologic surgery
Efficacy and Safety of Liposomal Bupivacaine Under ERAS Concept for Postoperative Analgesia of Ultrasound-Guided QLB in Gynecologic Laparoscopic Patients: A Randomized, Single-blind, Active-Controlled Clinical Study
This study is testing if a new pain relief method using liposomal bupivacaine can help women recover better after laparoscopic gynecologic surgery while reducing the need for opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Tianjin Medical University General Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT06288841 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of liposomal bupivacaine as part of a multimodal analgesia approach under the Enhanced Recovery After Surgery (ERAS) concept for patients undergoing laparoscopic gynecologic procedures. The study involves administering liposomal bupivacaine through a quadratus lumbar block (QLB) to manage postoperative pain effectively. By optimizing pain management, the trial aims to reduce opioid use and improve recovery outcomes such as postoperative nausea and vomiting (PONV) and length of hospital stay. Participants will be monitored for pain relief and any potential side effects associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with ASA grade I or II who are scheduled for elective laparoscopic hysterectomy or laparoscopic hysterectomy with double adnexectomy.
Not a fit: Patients with a history of allergies to the study drugs, severe comorbidities, or those requiring conversion to open surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve postoperative pain management and recovery for patients undergoing laparoscopic gynecologic surgery.
How similar studies have performed: Previous studies have shown promising results with similar multimodal analgesia approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1) Age 18-65 years; 2) ASA grade I or II; 3) Patients who are scheduled to undergo elective laparoscopic hysterectomy or laparoscopic hysterectomy and double adnexectomy; 4) BMI of 19-29 kg/m2; 5) Patients who voluntarily sign the informed consent form. Exclusion Criteria: * 1) Those who are known to be allergic to the drug components of this study and have allergic constitution; 2) History of allergy to general anesthetic drugs, opioids, and non-steroidal drugs; 3) Patients who need to switch to laparotomy for various reasons; 4) history of neurological disease; History of chronic pain; drug addiction and alcohol abuse; History of long-term opioid use; Opioids are given 48 hours before surgery; 5) ASA grade III or IV; 6) Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, liver and kidney function, and obvious abnormalities in electrolytes; 7) Patients with severe gastrointestinal diseases; 8) Patients who refuse to use intravenous PCIA for analgesia; 9) Pregnant or lactating women; 10) Patients with infection in the skin of the abdominal injection area; 11) Patients with rheumatoid or inflammatory arthritis or diseases requiring chronic analgesic treatment; 12) Patients who have been treated for deep vein thrombosis, pulmonary embolism, myocardial infarction or ischemic stroke in the past 6 months; 13) Those who have poor compliance and cannot complete the test according to the research protocol; 14) Those who have participated in clinical trials of other drugs in the past 4 weeks; 15) Any circumstances that, in the opinion of the investigators, are not suitable for inclusion.
Where this trial is running
Tianjin, Tianjin
- Tianjin Medical University General Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Ning Luo
- Email: ningluo1996@163.com
- Phone: 13622098703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.