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Completed

NCT Number: NCT06429163

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Petersburg State University Hospital

Saint Petersburg, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Score

    Time frame: 4 hours postoperatively

    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.

Secondary outcomes

  1. Pain Score Dynamics

    Time frame: 2, 6, 8, 12, and 24 hours postoperatively

    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. Mobilization

    Time frame: Early postoperative period

    Timing of post-surgery mobilization (hours after surgery)

  3. Opioid Use

    Time frame: Postoperative period, up to 48 hours

    Number of opioid administrations

  4. Pain Localisation (Superficial/Deep)

    Time frame: Within 48 hours after surgery

    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.

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study title

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

Acronym: WINPLEX

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 24, 2024
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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