NCT06429163

Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy

Impact of Pre-incisional Wound Infiltration and Hypogastric Plexus Block Using Ropivacaine on Postoperative Pain Following Laparoscopic Myomectomy: A Single-Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Saint Petersburg State University, Russia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess an impact of laparoscopic superior hypogastric plexus (SHP) block combined with preemptive troacar site infiltration on postoperative pain intensity following laparoscopic myomectomy.

Detailed description

Patients randomized into 3 groups with a target ratio of 1:1:1 were included in the study: group 1 received standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block; group 2 received troacar site infiltration without SHP block; control group (group 3) received standard systemic analgesia alone. The primary endpoint was presented by assessing pain intensity using the numeric rating scale (NRS) at 4 hours postoperatively. Secondary endpoints included NRS dynamics at 2, 6, 8, 12, and 24 hours postoperatively, time to first mobilization, opioid use, and pain quality assessment.

Conditions

• Fibroid Uterus
• Pain, Postoperative

Interventions

Type	Name	Description
PROCEDURE	Troacar site infiltration	Infiltration of the anterior abdominal wall is performed with placebo or 0.2% ropivacaine diluted with physiological saline on a syringe in the volume of 20 ml - 5 ml for each incision. The drug is injected with a 22-gauge needle at a 90-degree angle.
PROCEDURE	Superior hypogastric plexus block	At the beginning of the operation the camera is used to visualise the area of the promontorium. Next, a 1 mm laparoscopic puncture needle is inserted through a trocar in the suprapubic region and plunged into the upper part of the formed dome to a depth of no more than 1 cm. After positioning the needle retroperitoneally, an aspiration test is performed to prevent intravascular injection. Then, 20 ml of placebo or 0.2% ropivacaine diluted with physiological saline is slowly injected. At the end of the procedure, the retroperitoneal space swollen by the local anaesthetic is visualised in the promontorium.

Timeline

• Start date: 2024-05-14
• Primary completion: 2025-01-26
• Completion: 2025-01-26
• First posted: 2024-05-24
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

1 site across 1 country: Russia