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Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy

RecruitingNAAges 35 Years - 75 YearsFemaleSerkan Kumbasar
NCT07435909 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Bupivacaine %0.5 (hyperbaric)
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Where

1 site
SBÜ Gaziosmanpaşa Training and Research Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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