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

S

Saint Petersburg State University, Russia

Status

Enrolling

Conditions

Fibroid Uterus
Pain, Postoperative

Treatments

Procedure: Infiltration of the anterior abdominal wall
Procedure: Upper hypogastric plexus blockade

Study type

Interventional

Funder types

Other

Identifiers

NCT06429163
WINPLEX

Details and patient eligibility

About

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

Full 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.

Enrollment

198 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with large nodal (≥ 6 cm) and/or multiple uterine myomas who are indicated for surgical treatment in the scope of laparoscopic myomectomy on the basis of the gynaecological department of the Pirogov Gynecological Centre of St. Petersburg State University,
  • age - 18 years and over,
  • informed consent of patients to participate in the research study

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 the opinion of the physician, precludes participation in the study,
  • the need for abdominal drainage,
  • severe adhesions in the sacral region

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

198 participants in 3 patient groups, including a placebo group

Standart analgesia
Placebo Comparator group
Description:
Standard variant of postoperative analgesia (systemic administration - intravenous, intramuscular, oral - non-steroidal anti-inflammatory drugs, paracetamol, opioid analgesics).
Treatment:
Procedure: Upper hypogastric plexus blockade
Procedure: Infiltration of the anterior abdominal wall
Pre-incisional infiltration
Active Comparator group
Description:
Prophylactic pre-incisional infiltration of the anterior abdominal wall + standard variant of postoperative analgesia
Treatment:
Procedure: Infiltration of the anterior abdominal wall
Presacral blockade
Active Comparator group
Description:
Prophylactic pre-incisional infiltration of the anterior abdominal wall + presacral blockade + standard variant of postoperative analgesia
Treatment:
Procedure: Upper hypogastric plexus blockade

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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