Hysterectomy Clinical Trials

Clinical trials related to Hysterectomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 35
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Turkey
SBÜ Gaziosmanpaşa Training and Research Hospital
RECRUITING
Istanbul
Contact Information
Primary
serkan kumbasar, md
drserkankumbasar@hotmail.com
5067873216
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2026-06-04
Participants
Target number of participants: 120
Treatments
Experimental: Intervention Group (Bupivacaine Group)
Participants undergoing total laparoscopic hysterectomy will receive 0.5% bupivacaine infiltration at the end of surgery. A total of 10 mL solution will be administered: 5 mL to the 10 mm trocar site and 5 mL distributed among the three 5 mm trocar sites. In addition, bupivacaine will be injected into the vaginal cuff region prior to trocar removal. All other perioperative management and postoperative analgesia protocols will be standardized.
No_intervention: Control Group
Participants undergoing total laparoscopic hysterectomy will not receive local anesthetic infiltration at the trocar sites or vaginal cuff. All other surgical procedures and postoperative analgesia protocols will be identical to those of the intervention group.
Related Therapeutic Areas
Sponsors
Leads: Serkan Kumbasar

This content was sourced from clinicaltrials.gov