## Protocol Section
### Identification Module
**NCT ID:** NCT06429163

**Acronym:** WINPLEX

**Brief Title:** Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy

**Official Title:** Влияние прединцизионной инфильтрации ран и блокады гипогастрального нервного сплетения с использованием ропивакаина на болевой синдром после лапароскопической миомэктомии. Одноцентровое проспективное рандомизированное плацебо-контролируемое двойное слепое экспериментальное исследование

#### Organization Study ID Info
**ID:** WINPLEX
#### Organization
**Class:** OTHER
**Full Name:** Saint Petersburg State University, Russia
### Status Module
#### Completion Date
**Date:** 2024-11-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-11-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Saint Petersburg State University, Russia

#### Responsible Party

**Investigator Affiliation:** Saint Petersburg State University, Russia

**Investigator Full Name:** Nikita Kharlov

**Investigator Title:** Head of Gynecology department

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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

**Detailed 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.

### Conditions Module

**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)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** A single-centre prospective randomized placebo-controlled double-blind pilot study

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** All patients and clinicians involved in the study are unaware of the group assignment and syringe contents.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 198

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Standard variant of postoperative analgesia (systemic administration - intravenous, intramuscular, oral - non-steroidal anti-inflammatory drugs, paracetamol, opioid analgesics).

**Intervention Names:**

- Procedure: Infiltration of the anterior abdominal wall

- Procedure: Upper hypogastric plexus blockade

**Label:** Standart analgesia

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Prophylactic pre-incisional infiltration of the anterior abdominal wall + standard variant of postoperative analgesia

**Intervention Names:**

- Procedure: Infiltration of the anterior abdominal wall

**Label:** Pre-incisional infiltration

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Prophylactic pre-incisional infiltration of the anterior abdominal wall + presacral blockade + standard variant of postoperative analgesia

**Intervention Names:**

- Procedure: Upper hypogastric plexus blockade

**Label:** Presacral blockade

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pre-incisional infiltration

- Standart analgesia

**Description:** Infiltration of the anterior abdominal wall is performed with 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.

**Name:** Infiltration of the anterior abdominal wall

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Presacral blockade

- Standart analgesia

**Description:** 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 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.

**Name:** Upper hypogastric plexus blockade

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Frequency of severe pain syndrome (≥ 4 points on the visual analogue scale) in the postoperative period after laparoscopic conservative myomectomy.

**Measure:** Frequency of severe pain syndrome

**Time Frame:** In the postoperative period, an average of 2 days

#### Secondary Outcomes

**Description:** Timing of post-surgery mobilization (hours after surgery)

**Measure:** Mobilization

**Time Frame:** In the early postoperative period, an average of 24 hours

**Description:** Frequency of opioid analgesic requirements

**Measure:** Opioid analgesic

**Time Frame:** In the early postoperative period, an average of 24 hours

**Description:** A questionnaire is administered to patients to determine the nature of pain: localisation of pain and conditions of its onset are noted The questionnaire indicates the localisation of pain (anterior abdominal wall, small pelvis, right shoulder), the conditions of its occurrence (lying, standing, and during the stress test).

**Measure:** Localisation of pain syndrome

**Time Frame:** In the postoperative period, an average of 2 days

**Description:** patients fill out the EQ-5D questionnaire to assess the patient's impressions of her hospital stay. EQ-5D is a multidimensional tool for assessing the quality of life, which can be expressed using a single indicator - an index. In this regard, it is also called a health index. Each component is divided into three levels according to the severity of the problem: no problem, moderately severe problem, severe problem. Combining these levels in five components allows to get 243 variants of 'health status'. The second part of the questionnaire is a visual analogue scale, the so-called 'health thermometer'. This is a twenty-centimetre vertical graduated ruler with 0 representing the worst and 100 representing the best state of health.

**Measure:** Patients' satisfaction level

**Time Frame:** At discharge, an average 2 days after surgery

**Description:** The Picker Patient Experience Questionnaire is designed for patient evaluation of 7 aspects of care: information, consistency, psychological aspect, consideration of patient preferences, physical well-being, involvement of family and friends, and continuity of care laparoscopic myomectomy performed. The total score is calculated as a percentage (0 - no problem in any aspect, 100 - presence of problems in all domains).

**Measure:** level of problems on different aspects of functioning

**Time Frame:** At discharge, an average 2 days after surgery

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Saint Petersburg

**Contacts:**

***Contact 1:***

- **Email:** nikita.kharlov@gmail.com

- **Name:** Nikita Kharlov

- **Phone:** 89262839377

- **Role:** CONTACT

**Country:** Russian Federation

**Facility:** Saint Petersburg State University Hospital

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009379

- Term: Neoplasms, Muscle Tissue

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009372

- Term: Neoplasms, Connective Tissue

- ID: D000003240

- Term: Connective Tissue Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Pain, Postoperative

- ID: M10901

- Name: Leiomyoma

- Relevance: HIGH

- As Found: Fibroid Uterus

- ID: M25846

- Name: Myofibroma

- Relevance: HIGH

- As Found: Fibroid Uterus

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12317

- Name: Neoplasms, Connective Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007889

- Term: Leiomyoma

- ID: D000047708

- Term: Myofibroma

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M1700

- Name: Ropivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
