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

Last updated: January 29, 2025
Sponsor: Saint Petersburg State University, Russia
Overall Status: Completed

Phase

N/A

Condition

Uterine Fibroids

Sarcoma (Pediatric)

Uterina Myoma

Treatment

Infiltration of the anterior abdominal wall

Upper hypogastric plexus blockade

Clinical Study ID

NCT06429163
WINPLEX
  • Ages > 18
  • Female

Study Summary

The purpose of this study is to evaluate the effectiveness of a comprehensive approach to anesthesia in patients with uterine myoma using pre-incisional infiltration of the anterior abdominal wall and presacral blockade of the hypogastric nerve plexus during laparoscopic myomectomy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with large nodal (≥ 6 cm) and/or multiple uterine myomas who are indicatedfor surgical treatment in the scope of laparoscopic myomectomy on the basis of thegynaecological department of the Pirogov Gynecological Centre of St. PetersburgState University,

  • age - 18 years and over,

  • informed consent of patients to participate in the research study

Exclusion

Exclusion Criteria:

  • conversion to laparotomy,

  • subserous uterine myoma 'on a pedicle' (type 7 according to FIGO),

  • the start of the surgical intervention is after 15.00,

  • presence of malignant diseases, diabetes mellitus, external genital endometriosis of 3-4 stage,

  • presence of psychiatric and cognitive impairment in female patients that, in theopinion of the physician, precludes participation in the study,

  • the need for abdominal drainage,

  • severe adhesions in the sacral region

Study Design

Total Participants: 198
Treatment Group(s): 2
Primary Treatment: Infiltration of the anterior abdominal wall
Phase:
Study Start date:
May 14, 2024
Estimated Completion Date:
January 26, 2025

Study Description

On admission, patients will complete the EQ-5D quality of life questionnaire to assess the level of problems including pain, anxiety and depression, as well as the level of quality of life in general. The Central Sensitization Inventory (CSI-R) is also completed.

Each patient is randomly assigned to one of three groups on admission: standard variant of postoperative analgesia (systemic administration - intravenous, intramuscular, oral - non-steroidal anti-inflammatory drugs, paracetamol, opioid analgesics), prophylactic pre-incisional infiltration of the anterior abdominal wall + standard variant of postoperative analgesia or prophylactic pre-incisional infiltration of the anterior abdominal wall + presacral blockade + standard variant of postoperative analgesia. Randomisation is done in a 1:1:1 ratio. In the early postoperative period, a questionnaire is administered to patients to determine the intensity and nature of pain: hourly VAS value, localisation of pain and conditions of its onset are noted. At discharge, patients fill out the EQ-5D questionnaire and the Picker questionnaire to assess the patient's impressions of her hospital stay.

Connect with a study center

  • Saint Petersburg State University Hospital

    Saint Petersburg,
    Russian Federation

    Site Not Available

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