Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy
- Conditions
- Fibroid UterusPain, Postoperative
- Interventions
- Procedure: Infiltration of the anterior abdominal wallProcedure: Upper hypogastric plexus blockade
- Registration Number
- NCT06429163
- Lead Sponsor
- Saint Petersburg State University, Russia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 198
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standart analgesia Upper hypogastric plexus blockade Standard variant of postoperative analgesia (systemic administration - intravenous, intramuscular, oral - non-steroidal anti-inflammatory drugs, paracetamol, opioid analgesics). Standart analgesia Infiltration of the anterior abdominal wall Standard variant of postoperative analgesia (systemic administration - intravenous, intramuscular, oral - non-steroidal anti-inflammatory drugs, paracetamol, opioid analgesics). Pre-incisional infiltration Infiltration of the anterior abdominal wall Prophylactic pre-incisional infiltration of the anterior abdominal wall + standard variant of postoperative analgesia Presacral blockade Upper hypogastric plexus blockade Prophylactic pre-incisional infiltration of the anterior abdominal wall + presacral blockade + standard variant of postoperative analgesia
- Primary Outcome Measures
Name Time Method Frequency of severe pain syndrome In the postoperative period, an average of 2 days Frequency of severe pain syndrome (≥ 4 points on the visual analogue scale) in the postoperative period after laparoscopic conservative myomectomy.
- Secondary Outcome Measures
Name Time Method Opioid analgesic In the early postoperative period, an average of 24 hours Frequency of opioid analgesic requirements
Localisation of pain syndrome In the postoperative period, an average of 2 days 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).
Mobilization In the early postoperative period, an average of 24 hours Timing of post-surgery mobilization (hours after surgery)
Patients' satisfaction level At discharge, an average 2 days after surgery 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.
level of problems on different aspects of functioning At discharge, an average 2 days after surgery 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).
Trial Locations
- Locations (1)
Saint Petersburg State University Hospital
🇷🇺Saint Petersburg, Russian Federation