Trials
Search / Trial NCT06429163

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

Launched by SAINT PETERSBURG STATE UNIVERSITY, RUSSIA · May 20, 2024

Trial Information

Current as of February 18, 2025

Completed

Keywords

Uterine Fibroid Laparoscopic Myomectomy Postoperative Pain Pre Incisional Infiltration Hypogastric Plexus Block Eq 5 D Questionnaire Picker Questionnaire The Central Sensitization Inventory (Csi R)

ClinConnect Summary

This clinical trial is studying a new method to help manage pain for women undergoing a specific type of surgery called laparoscopic myomectomy, which is used to remove large or multiple fibroids from the uterus. The researchers want to see if combining two techniques—injecting a pain-relieving medication into the abdominal wall before surgery and blocking nerves that carry pain signals—can improve pain control during and after the procedure.

To be eligible for this trial, participants must be women aged 18 and older who have large fibroids (more than 6 cm) and need surgery. They should be able to give informed consent, meaning they understand the study and agree to participate. However, women with certain conditions, such as severe endometriosis, cancer, or those who need a different type of surgery, cannot take part. Participants can expect to receive specialized pain relief, and the study will help researchers learn more about the best ways to manage pain for future patients.

Gender

FEMALE

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

About Saint Petersburg State University, Russia

Saint Petersburg State University, established in 1724, is a prestigious institution in Russia known for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise to advance medical knowledge and improve patient outcomes through rigorous scientific investigation. With a focus on multidisciplinary collaboration, the university fosters partnerships with healthcare professionals, researchers, and industry stakeholders to conduct high-quality clinical trials that adhere to international standards. Its mission is to contribute to the global healthcare landscape by generating reliable data that informs clinical practices and therapeutic interventions.

Locations

Saint Petersburg, , Russian Federation

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0