Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429163
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-14
Brief Title:
Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy
Sponsor:
Saint Petersburg State University Russia
Organization:
Saint Petersburg State University Russia
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WINPLEX
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 111 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 patients impressions of her hospital stay
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 111 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 patients impressions of her hospital stay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None