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Trial Title:
Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy
NCT ID:
NCT06429163
Condition:
Fibroid Uterus
Pain, Postoperative
Conditions: Official terms:
Leiomyoma
Myofibroma
Pain, Postoperative
Conditions: Keywords:
Uterine fibroid
Laparoscopic myomectomy
Postoperative pain
Pre-incisional infiltration
Hypogastric plexus block
EQ-5D questionnaire
Picker questionnaire
The Central Sensitization Inventory (CSI-R)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A single-centre prospective randomized placebo-controlled double-blind pilot study
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Masking description:
All patients and clinicians involved in the study are unaware of the group assignment and
syringe contents.
Intervention:
Intervention type:
Procedure
Intervention name:
Infiltration of the anterior abdominal wall
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.
Arm group label:
Pre-incisional infiltration
Arm group label:
Standart analgesia
Intervention type:
Procedure
Intervention name:
Upper hypogastric plexus blockade
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.
Arm group label:
Presacral blockade
Arm group label:
Standart analgesia
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Saint Petersburg State University Hospital
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Nikita Kharlov
Phone:
89262839377
Email:
nikita.kharlov@gmail.com
Start date:
May 14, 2024
Completion date:
November 4, 2024
Lead sponsor:
Agency:
Saint Petersburg State University, Russia
Agency class:
Other
Source:
Saint Petersburg State University, Russia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06429163
