Uterine LeiomyomasNCT02829333
The Effect of Anesthetic Technique on VEGF-C and PGE2
A study testing spinal anesthesia and continuous postoperative epidural analgesia in people with Uterine Leiomyomas, run by General Hospital of Ningxia Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Leiomyomas
- What is being tested?
- spinal anesthesia and continuous postoperative epidural analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with leiomyomas requiring abdominal myomectomy, aged 18-65 year and American Society of Anesthesiologists (ASA) physical status I or II.
Who cannot join
- 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.
About this study
Official title: Effect of Anesthetic Technique on Serum Vascular Endothelial Growth Factor C and Prostaglandin E2 in Women Undergoing Surgery for Uterine Leiomyomas
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.
Read the 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.
- Conditions
- Uterine Leiomyomas
- Being tested
- general anesthesia and patient controlled intravenous analgesia, spinal anesthesia and continuous postoperative epidural analgesia
- Keywords
- analgesia, anesthesia, leiomyomas, tumor, vascular endothelial growth factor, anesthesia technique on tumor
- Medical subject headings
- Myofibroma, Agnosia, Leiomyoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesia and patient controlled intravenous analgesiaOther
Patients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation
spinal anesthesia and continuous postoperative epidural analgesiaOther
Patients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation
| Study group | Role | What they receive |
|---|---|---|
| Group GA | Other | 22 patients receive general anesthesia and patient controlled intravenous analgesia Receives: Other: general anesthesia and patient controlled intravenous analgesia |
| Group SA | Other | 22 patients receive spinal anesthesia and continuous postoperative epidural analgesia Receives: Other: spinal anesthesia and continuous postoperative epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Before anesthesia and at 48 hours after surgery
Secondary outcomes (1)
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
Measured: at 2h, 4h, 8h, 12h, 24h and 48h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine LeiomyomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829333
- Sponsor's protocol ID
- Zhangyonghai001
- Status last verified
- Jul 2016
- First submitted
- 5 Jul 2016
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthetic Technique on Serum Vascular Endothelial Growth Factor C and Prostaglandin E2 in Women Undergoing Surgery for Uterine Leiomyomas
- ClinicalTrials.gov ID
- NCT02829333
- Acronym / sponsor ID
- Zhangyonghai001
- Conditions
- Uterine Leiomyomas
- Keywords
- analgesia, anesthesia, leiomyomas, tumor, vascular endothelial growth factor, anesthesia technique on tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group GA | Other | Other: general anesthesia and patient controlled intravenous analgesia22 patients receive general anesthesia and patient controlled intravenous analgesia |
| Group SA | Other | Other: spinal anesthesia and continuous postoperative epidural analgesia22 patients receive spinal anesthesia and continuous postoperative epidural analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients with leiomyomas requiring abdominal myomectomy, aged 18-65 year and American Society of Anesthesiologists (ASA) physical status I or II.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general anesthesia and patient controlled intravenous analgesiaPatients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation | Other | Group GA |
| spinal anesthesia and continuous postoperative epidural analgesiaPatients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation | Other | Group SA |
Primary outcome
Change of vascular endothelial growth factor C before anesthesia and at 48 hours after surgery
Time frame: 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).
Change of prostaglandin E2 before anesthesia and at 48 hours after surgery
Time frame: 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).
1 secondary outcome
Visual analog scale (VAS) pain scores
Time frame: at 2h, 4h, 8h, 12h, 24h and 48h after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia and continuous postoperative epidural analgesia in people with Uterine Leiomyomas, run by General Hospital of Ningxia Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of vascular endothelial growth factor C before anesthesia and at 48 hours after surgery (time frame: Before anesthesia and at 48 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.