Clinical trial NCT06429163: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-centre prospective randomized placebo-controlled double-blind pilot study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of severe pain syndrome
timeFrame: In the postoperative period, an average of 2 days
Secondary outcomes:
measure: Mobilization
timeFrame: In the early postoperative period, an average of 24 hours
measure: Opioid analgesic
timeFrame: In the early postoperative period, an average of 24 hours
measure: Localisation of pain syndrome
timeFrame: In the postoperative period, an average of 2 days
measure: Patients' satisfaction level
timeFrame: At discharge, an average 2 days after surgery
measure: level of problems on different aspects of functioning
timeFrame: At discharge, an average 2 days after surgery
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State University Hospital
Study officials:
References: