NCT07435909 Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy
| NCT ID | NCT07435909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Serkan Kumbasar |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2026-06-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-08-28 with a primary completion date of 2026-06-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective, randomized, single-blind controlled study aims to evaluate the effect of bupivacaine injection at trocar entry sites and the vaginal cuff on postoperative pain in patients undergoing total laparoscopic hysterectomy for benign gynecologic conditions. Postoperative pain after laparoscopic hysterectomy may arise from trocar insertion sites and surgical manipulation of the vaginal cuff. Local anesthetic infiltration may reduce somatic pain and improve early recovery. Eligible patients will be randomly assigned to either receive 0.5% bupivacaine injection at trocar sites and the vaginal cuff at the end of surgery or receive no local anesthetic injection (control group). All patients will receive standard postoperative analgesia. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 1, 2, 3, 6, 12, and 24 hours after surgery. Secondary outcomes include additional analgesic requirement, time to first mobilization, time to first flatus, length of hospital stay, and postoperative complications.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07435909 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 75 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07435909 currently recruiting?
Yes, NCT07435909 is actively recruiting participants. Contact the research team at drserkankumbasar@hotmail.com for enrollment information.
Where is the NCT07435909 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07435909 clinical trial?
NCT07435909 is sponsored by Serkan Kumbasar. The trial plans to enroll 120 participants.