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Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy

NCT07435909 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-27

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Bupivacaine %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.

Sponsors & Collaborators

  • Serkan Kumbasar

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2026-06-04
Completion
2026-06-04

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07435909 on ClinicalTrials.gov