Bupivacaine to reduce pain after laparoscopic hysterectomy
Effect of Trocar Site and Vaginal Cuff Bupivacaine Injection on Postoperative Pain in Patients Undergoing Total Laparoscopic Hysterectomy
This trial will test whether injecting 0.5% bupivacaine around the trocar sites and into the vaginal cuff at the end of a laparoscopic hysterectomy reduces early postoperative pain for women having the operation for benign conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | Female |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 1 site (Istanbul, gaziosmanpaşa) |
| Trial ID | NCT07435909 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, single-blind controlled trial comparing intraoperative local infiltration of 0.5% bupivacaine at trocar entry sites and the vaginal cuff with no local anesthetic injection in patients undergoing total laparoscopic hysterectomy for benign indications. All participants receive standard postoperative analgesia while pain is measured with a visual analog scale at 1, 2, 3, 6, 12 and 24 hours after surgery. Secondary outcomes include additional analgesic requirements, time to first mobilization, time to first flatus, and length of hospital stay. The intervention delivers a total of 10 mL (5 mL 0.5% bupivacaine diluted with 5 mL saline) with targeted injections under laparoscopic visualization.
Who should consider this trial
Good fit: Women aged 35–75 scheduled for total laparoscopic hysterectomy for benign gynecologic conditions, ASA class I–II, cognitively able to report pain, and who complete the surgery laparoscopically are the intended participants.
Not a fit: Patients with suspected or confirmed malignant gynecologic disease, known allergy to bupivacaine, chronic pain syndromes or analgesic dependence, or those converted to laparotomy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce early postoperative pain and opioid use, helping patients mobilize and recover sooner.
How similar studies have performed: Previous studies of trocar-site infiltration with local anesthetic have reported mixed results, and combined trocar-site plus vaginal cuff infiltration is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 35-75 years * Scheduled for total laparoscopic hysterectomy for benign gynecologic conditions, including leiomyoma uteri, adenomyosis, abnormal uterine bleeding, endometrial pathology (non-atypical hyperplasia, endometrial thickening, or polyps), cervical intraepithelial lesions (CIN 2-3) without evidence of invasion and indicated for therapeutic hysterectomy, chronic pelvic pain, or benign uterine prolapse * American Society of Anesthesiologists (ASA) physical status class I-II * Cognitive ability sufficient to assess and report postoperative pain (no dementia or severe psychiatric disorder) * Provision of written informed consent * Completion of surgery laparoscopically as planned (no conversion to laparotomy) Exclusion Criteria: * Presence or suspicion of malignant gynecologic disease * History of allergy or hypersensitivity to bupivacaine or other amide-type local anesthetics * History of chronic pain syndrome, analgesic dependence, or regular use of opioids or nonsteroidal anti-inflammatory drugs (NSAIDs) * Severe systemic disease (e.g., uncontrolled diabetes mellitus, hepatic or renal insufficiency, or heart failure) * Neurological or psychiatric disorders that impair the ability to assess or report pain
Where this trial is running
Istanbul, gaziosmanpaşa
- SBÜ Gaziosmanpaşa Training and Research Hospital — Istanbul, gaziosmanpaşa, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: serkan kumbasar, md
- Email: drserkankumbasar@hotmail.com
- Phone: 5067873216
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.