NCT07435909

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Serkan Kumbasar · Other Government
• Sex: Female
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Total laparoscopic hysterectomy (TLH) is widely performed for benign gynecologic conditions and is associated with shorter hospital stay and faster recovery compared with open surgery. However, postoperative pain remains a relevant clinical concern. Pain after TLH may originate from abdominal trocar entry sites as well as surgical manipulation and suturing of the vaginal cuff. Local anesthetic infiltration is a component of multimodal analgesia strategies aimed at reducing postoperative pain and opioid consumption. Bupivacaine, a long-acting amide-type local anesthetic, has been used for surgical wound infiltration with variable results. While previous studies have evaluated trocar site infiltration alone, limited data are available regarding the combined infiltration of both trocar sites and the vaginal cuff in patients undergoing TLH. This study is designed as a prospective, randomized, single-blind controlled trial conducted at a tertiary referral center. Eligible patients undergoing TLH for benign indications will be randomized into two groups. In the intervention group, a total of 10 mL solution containing 5 mL of 0.5% bupivacaine (Marcaine) diluted with 5 mL normal saline will be administered at the end of surgery. Under laparoscopic visualization, 1 mL of the solution will be injected bilaterally into the sacrouterine ligament regions adjacent to the vaginal cuff (a total of 2 ml into both sacrouterin ligaments). After trocar removal, the remaining solution will be infiltrated into the trocar entry sites using an injector from the subcutaneous tissue down to the fascial layer (approximately 2 mL per trocar site). The control group will not receive local anesthetic infiltration. All surgical procedures will be performed using a standardized TLH technique by the same surgical team. Pain intensity will be assessed using repeated measurements over the first 24 postoperative hours. The study will also evaluate recovery-related parameters and safety outcomes. Statistical analysis will be performed using mixed-effects modeling to account for repeated pain measurements over time, with a two-sided significance level of 0.05.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine %0.5 (hyperbaric)	Participants undergoing total laparoscopic hysterectomy will receive 0.5% bupivacaine infiltration at the end of surgery. A total of 12 mL of 0.5% bupivacaine will be administered: 2 mL to each of the four trocar sites (total 8 mL) and 2 mL bilaterally to the vaginal cuff (total 4 mL) prior to trocar removal. All other perioperative management and postoperative analgesia protocols will be standardized.

Timeline

• Start date: 2025-08-28
• Primary completion: 2026-06-04
• Completion: 2026-06-04
• First posted: 2026-02-27
• Last updated: 2026-03-10

Locations

1 site across 1 country: Turkey (Türkiye)