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

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

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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