Actively Recruiting

Phase Not Applicable
Age: 35Years - 75Years
FEMALE
NCT07435909

Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy

Led by Serkan Kumbasar · Updated on 2026-03-10

120

Participants Needed

1

Research Sites

40 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy

Who Can Participate

Age: 35Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 35 to 75 years
  • Scheduled for total laparoscopic hysterectomy for benign gynecologic conditions such as leiomyoma uteri, adenomyosis, abnormal uterine bleeding, non-atypical endometrial pathology, cervical intraepithelial lesions without invasion, chronic pelvic pain, or benign uterine prolapse
  • American Society of Anesthesiologists (ASA) physical status class I or II
  • Able to assess and report postoperative pain (no dementia or severe psychiatric disorder)
  • Provided written informed consent
  • Surgery completed laparoscopically as planned without conversion to laparotomy
Not Eligible

You will not qualify if you...

  • Presence or suspicion of malignant gynecologic disease
  • Allergy or hypersensitivity to bupivacaine or other amide-type local anesthetics
  • History of chronic pain syndrome, analgesic dependence, or regular use of opioids or NSAIDs
  • Severe systemic diseases such as uncontrolled diabetes, liver or kidney failure, or heart failure
  • Neurological or psychiatric disorders impairing ability to assess or report pain

AI-Screening

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Trial Site Locations

Total: 1 location

1

SBÜ Gaziosmanpaşa Training and Research Hospital

Istanbul, gaziosmanpaşa, Turkey (Türkiye)

Actively Recruiting

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Research Team

S

serkan kumbasar, md

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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