The Effect of Anesthetic Technique on VEGF-C and PGE2

Not Applicable

Completed

• Conditions: Uterine Leiomyomas
• Interventions: Other: spinal anesthesia and continuous postoperative epidural analgesia; Other: general anesthesia and patient controlled intravenous analgesia

• Registration Number: NCT02829333
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

The purpose of this study is to verify the effect of anesthetic technique on the change of postoperative serum vascular endothelial growth factor C and prostaglandin E2, and to explore the potential impact of the anesthetic technique on leiomyomas recurrence and growth after the surgery of abdominal myomectomy.

Detailed Description

Uterine leiomyomas is the most common benign tumor of uterus, the most common tumor in women as well. Like many other forms of tumor, it requires an independent blood supply to enlarge. This process, angiogenesis, is mediated by vascular endothelial growth factor C (VEGF-C) and prostaglandin E2 (PGE2). Several studies have confirmed that VEGF-C has a high level in patients with uterine leiomyomas, which has also been demonstrated that it was related to occurrence and growth of uterine leiomyomas because it's capable of promoting angiogenesis, mitogenic, and vascular permeability-enhancing activities. Also, some researchers suggested that suppression of prostaglandin synthesis (including PGE2) via cyclooxygenase type-2 (COX-2) enzyme inhibition may reduce the incidence of some tumor. The aim of this study is to verify the effect of anesthetic technique on the change of postoperative serum VEGF-C and PGE2, and to explore the potential impact of the anesthetic technique on leiomyomas recurrence and growth after the surgery of abdominal myomectomy.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-07
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-12
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• The patients with leiomyomas requiring abdominal myomectomy, aged 18-65 year and American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion Criteria

• The patients who had a history of surgery within the preceding two weeks, a history of blood transfusion and a history of coronary artery disease, any contraindication to spinal anesthesia or opioid analgesia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group SA	spinal anesthesia and continuous postoperative epidural analgesia	22 patients receive spinal anesthesia and continuous postoperative epidural analgesia
Group GA	general anesthesia and patient controlled intravenous analgesia	22 patients receive general anesthesia and patient controlled intravenous analgesia

Primary Outcome Measures

Name	Time	Method
Change of prostaglandin E2 before anesthesia and at 48 hours after surgery	Before anesthesia and at 48 hours after surgery	Blood samples were sampled before anesthesia and at 48h after surgery for the serum PGE2，which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Change of vascular endothelial growth factor C before anesthesia and at 48 hours after surgery	Before anesthesia and at 48 hours after surgery	Blood samples were sampled before anesthesia and at 48h after surgery for the serum VEGF-C，which were analyzed by using enzyme linked immunosorbent assay (ELISA).

Secondary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) pain scores	at 2h, 4h, 8h, 12h, 24h and 48h after surgery	Visual analog scale (VAS) pain scores were used to evaluate postoperative pain at 2h, 4h, 8h, 12h, 24h and 48h after surgery by the anesthetist