The Effect of Anesthetic Technique on VEGF-C and PGE2

Study Overview
=================
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.

Official Title
-----------------
Effect of Anesthetic Technique on Serum Vascular Endothelial Growth Factor C and Prostaglandin E2 in Women Undergoing Surgery for Uterine Leiomyomas

Conditions
-----------------
Uterine Leiomyomas

Intervention / Treatment
-----------------
* Other: general anesthesia and patient controlled intravenous analgesia
* Other: spinal anesthesia and continuous postoperative epidural analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group GA<br>22 patients receive general anesthesia and patient controlled intravenous analgesia | Other: general anesthesia and patient controlled intravenous analgesia<br>* Patients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation<br>|
| Other: Group SA<br>22 patients receive spinal anesthesia and continuous postoperative epidural analgesia | Other: spinal anesthesia and continuous postoperative epidural analgesia<br>* Patients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of vascular endothelial growth factor C 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). | Before anesthesia and at 48 hours after surgery | 
| Change of prostaglandin E2 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). | Before anesthesia and at 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) pain scores | 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 | at 2h, 4h, 8h, 12h, 24h and 48h after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia, anesthesia, leiomyomas, tumor, vascular endothelial growth factor, anesthesia technique on tumor