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

NCT06429163 | Completed Results

• 1 other identifier: WINPLEX
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibroid Uterus; Pain, Postoperative

Keywords

Uterine fibroid; Laparoscopic myomectomy; Postoperative pain; Pre-incisional infiltration; Hypogastric plexus block; EQ-5D questionnaire; Picker questionnaire; The Central Sensitization Inventory (CSI-R)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain Score Dynamics

  2, 6, 8, 12, and 24 hours postoperatively

• Mobilization

  Early postoperative period

• Opioid Use

  Postoperative period, up to 48 hours

• Pain Localisation (Superficial/Deep)

  Within 48 hours after surgery

Study Arms (3)

Standart analgesia

PLACEBO COMPARATOR

Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).

Procedure: Troacar site infiltration; Procedure: Superior hypogastric plexus block

Troacar site infiltration

ACTIVE COMPARATOR

Troacar site infiltration without SHP block

Procedure: Troacar site infiltration; Procedure: Superior hypogastric plexus block

SHP block

EXPERIMENTAL

Standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block

Procedure: Troacar site infiltration; Procedure: Superior hypogastric plexus block

Interventions

Troacar site infiltration PROCEDURE

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.

SHP block; Standart analgesia; Troacar site infiltration

Superior hypogastric plexus block PROCEDURE

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.

SHP block; Standart analgesia; Troacar site infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint Petersburg State University Hospital

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Leiomyoma; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Patient selection followed a per-protocol design rather than an intention-to-treat approach. This strategy was chosen deliberately, as the aim was not only to assess the efficacy and safety of the proposed technique, but also to refine its application during the surgical learning curve. Such a design ensured high group homogeneity and allowed evaluation of the method under optimal procedural conditions. However, it limited the generalizability of the findings to a broader patient population, par

Results Point of Contact

• Title: Nikita S. Kharlov
• Organization: Saint-Petersburg State University

nikita.kharlov@gmail.com

+7 926 283-93-77

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: All patients and clinicians involved in the study are unaware of the group assignment and syringe contents.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gynecology department

Model Details: A single-centre prospective randomized placebo-controlled double-blind pilot study

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 24, 2024
• Study Start: May 14, 2024
• Primary Completion: January 26, 2025
• Study Completion: January 26, 2025
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Locations

RU (1)