RecruitingNot ApplicableNCT07435909

Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy

Effect of Trocar Site and Vaginal Cuff Bupivacaine Injection on Postoperative Pain in Patients Undergoing Total Laparoscopic Hysterectomy

Sponsor

Serkan Kumbasar

Enrollment

120 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain

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

Sex: FEMALEMin Age: 35 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria5

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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Interventions

DRUGBupivacaine %0.5 (hyperbaric)

Participants undergoing total laparoscopic hysterectomy will receive 0.5% bupivacaine infiltration at the end of surgery. A total of 10 mL of 0.5% bupivacaine will be administered: 2 mL to each of the four trocar sites (total 8 mL) and 1 mL bilaterally to the vaginal cuff (total 2 mL) prior to trocar removal. All other perioperative management and postoperative analgesia protocols will be standardized.