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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Fibroid Uterus
• Intervention / Treatment: Procedure: Troacar site infiltration; Procedure: Superior hypogastric plexus block

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.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Saint Petersburg, Russia
    • Saint Petersburg State University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Women aged ≥18 years.
• Indication for laparoscopic myomectomy due to ≥6 cm fibroid(s) or multiple fibroids.
• Ability to provide informed consent.

Exclusion Criteria

• FIGO type 7 subserosal pedunculated myoma.
• Conversion to laparotomy.
• Severe presacral adhesions preventing safe SHPB.
• Concomitant pelvic or abdominal surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standart analgesia; Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).	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.
Active Comparator: Troacar site infiltration; Troacar site infiltration without SHP block	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.
Experimental: SHP block; Standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Pain syndrome intensity 4 hours after laparoscopic myomectomy. The NRS (Numeric Rating Scale) score from 0-10 is a tool for self-reporting pain intensity, where 0 equals no pain and 10 equals the worst pain imaginable.	4 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score Dynamics	The NRS (Numeric Rating Scale) score from 0-10 is a tool for self-reporting pain intensity, where 0 equals no pain and 10 equals the worst pain imaginable.	2, 6, 8, 12, and 24 hours postoperatively
Mobilization	Timing of post-surgery mobilization (hours after surgery)	Early postoperative period
Opioid Use	Number of opioid administrations	Postoperative period, up to 48 hours
Pain Localisation (Superficial/Deep)	Patients were asked to characterize the predominant type of postoperative pain using a standardized questionnaire. Superficial pain was defined as somatic pain (localized, similar to muscle soreness), while deep pain was defined as visceral (diffuse, dull, similar to menstrual pain). Responses were used to evaluate the visceral pain component after surgery. Participants were allowed to report more than one type of postoperative pain.	Within 48 hours after surgery

Collaborators and Investigators

• Sponsor: Saint Petersburg State University, Russia

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Actual): January 26, 2025
• Study Completion (Actual): January 26, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative pain; Uterine fibroid; EQ-5D questionnaire; Laparoscopic myomectomy; Pre-incisional infiltration; Hypogastric plexus block; Picker questionnaire; The Central Sensitization Inventory (CSI-R)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Leiomyoma
• Other Study ID Numbers: WINPLEX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No