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

Pain, Postoperative Clinical Trial

— WINPLEX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429163
• Other study ID #: WINPLEX
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: November 4, 2024

Study information

• Verified date: May 2024
• Source: Saint Petersburg State University, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: November 4, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibroid Uterus
• Leiomyoma
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Saint Petersburg State University Hospital	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of severe pain syndrome	Frequency of severe pain syndrome (= 4 points on the visual analogue scale) in the postoperative period after laparoscopic conservative myomectomy.	In the postoperative period, an average of 2 days
Secondary	Mobilization	Timing of post-surgery mobilization (hours after surgery)	In the early postoperative period, an average of 24 hours
Secondary	Opioid analgesic	Frequency of opioid analgesic requirements	In the early postoperative period, an average of 24 hours
Secondary	Localisation of pain syndrome	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).	In the postoperative period, an average of 2 days
Secondary	Patients' satisfaction level	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.	At discharge, an average 2 days after surgery
Secondary	level of problems on different aspects of functioning	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).	At discharge, an average 2 days after surgery