Epidural; Anesthesia, HeadacheNCT04629573
Epidural Anesthesia and Myomectomy Associated Bleeding
A study testing Lumber Epidural and General anesthesia in people with Epidural; Anesthesia, Headache, run by Assiut University at 1 site in Egypt.
Trial summary
This is a prospective study for abdominal myomectomies performed from June 2012 to June 2019 by a single surgeon in a tertiary care referral hospital. Large uterine myoma was defined as the estimated diameter of dominant myoma equal to or larger than 10 cm by sonography. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epidural; Anesthesia, Headache
- What is being tested?
- Lumber Epidural and General anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to Sep 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18 years old
- American Society of Anesthesiologist (ASA) I and II
- Undergoing myomectomy for treatment of large uterine leiomyomas with a minimum diameter of 10 cm
Who cannot join
- Patients with previous uterine surgery (myomectomy, cesarean delivery)
- Coagulopathy or other bleeding diathesis
- Severe anemia (Hb under 5.0 g/dl)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidural Anesthesia and Myomectomy-Associated Blood Loss: A Prospective Randomised Controlled Study
This is a prospective study for abdominal myomectomies performed from June 2012 to June 2019 by a single surgeon in a tertiary care referral hospital. Large uterine myoma was defined as the estimated diameter of dominant myoma equal to or larger than 10 cm by sonography. Demographics, diagnosis, perioperative variables, operative outcomes and complications were recorded. The Intraoperative anesthetic management, blood and blood products transfusion, and total volume of blood loss, as well as postoperative follow-up, were reviewed for each patient.
Read the detailed description
Randomization and Blinding: To allow randomization, researchers prepared the management protocol for each group and sealed one protocol per envelope with a computer-generated number assigned prior to study initiation. Randomization was performed by picking the numbered study envelopes sequentially and opened before induction of anesthesia by the anesthesia doctor and managing the participant based on the enclosed protocol. The study will not be double-blinded, as it is impossible to blind the health care workers and women involved for the strategy to which the woman is allocated.
Interventions Anesthesia technique: On arrival to the operative theatre, an 18 gauge IV catheter was inserted and 500 ml of NaCl (0.9%) was infused, 1 mg midazolam was administered iv as premedication. Patients were monitored with continuous electrocardiography and pulse oximetry and intermittent non-invasive blood pressure measurements every 5 min.
Lumbar epidural: Epidural procedure was performed by attending anesthesiologists who had completed at least 50 epidural procedures during their training. Patient was placed in the sitting position, the skin over the lumbar area was cleaned and a sterile technique was observed throughout the procedure. Skin and subcutaneous tissue were infiltrated with 1% lidocaine 2 mL at the intended site of epidural placement (L2-3 or L3-4 interspace). The lumbar epidural space was then located, using a midline approach with an 18 gauge Tuohy epidural needle via a loss of resistance technique with 2 mL of saline, 20 gauge epidural catheter was placed in each patient. We deliver an initial bolus of 20 ml bupivacaine 0.5% plus 100 mcg Fentanyl, followed by continuous infusion of bupivacaine 0.5% plus 1mcg/ml Fentanyl (3-5 ml/hr.).
General anesthesia: Anesthesia was initiated with IV fentanyl 1 µg/kg, propofol 2 mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation. After tracheal intubation, anesthesia was maintained with sevoflurane in O2 and air (FiO2 of 0.5), cisatracurium 1µg/kg/min and fentanyl 0.5 µg/ kg /h were infused. Volume-Controlled ventilation was performed in all patients. Cisatracurium and fentanyl infusion was stopped at the end of surgery, neuromuscular blockade was reversed, and the patient was extubated and send to post-anesthesia care unit.
Myomectomy: Abdominal myomectomy was performed in the standard conventional fashion. A single surgeon handled all the surgical procedures. The myomectomy was performed by enucleating the fibroid and closing the uterine defect in multiple layers. The use of energy devices, suture type, and adhesion barriers were at the discretion of the surgeon.
- Conditions
- Epidural; Anesthesia, Headache
- Being tested
- Lumber Epidural, General anesthesia
- Keywords
- Epidural anesthesia, Myomectomy
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumber EpiduralProcedure or surgery
Epidural procedure was performed by attending anesthesiologists who had completed at least 50 epidural procedures during their training. Patient was placed in the sitting position, the skin over the lumbar area was cleaned and a sterile technique was observed throughout the procedure. Skin and subcutaneous tissue were infiltrated with 1% lidocaine 2 mL at the intended site of epidural placement (L2-3 or L3-4 interspace). The lumbar epidural space was then located, using a midline approach with an 18 gauge Tuohy epidural needle via a loss of resistance technique with 2 mL of saline, 20 gauge epidural catheter was placed in each patient. We deliver an initial bolus of 20 ml bupivacaine 0.5% plus 100 mcg Fentanyl, followed by continuous infusion of bupivacaine 0.5% plus 1mcg/ml Fentanyl (3-5 ml/hr.).
General anesthesiaProcedure or surgery
Anesthesia was initiated with IV fentanyl 1 µg/kg, propofol 2 mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation. After tracheal intubation, anesthesia was maintained with sevoflurane in O2 and air (FiO2 of 0.5), cisatracurium 1µg/kg/min and fentanyl 0.5 µg/ kg /h were infused. Volume-Controlled ventilation was performed in all patients. Cisatracurium and fentanyl infusion was stopped at the end of surgery, neuromuscular blockade was reversed, and the patient was extubated and send to post-anesthesia care unit.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Epidural Anesthesia Receives: Procedure: Lumber Epidural |
| Group 2 | Active comparator | General Anesthesia Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Intraoperative blood loss
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study startJun 2014
- Primary completionAug 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidural; Anesthesia, HeadacheStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrady S Ibrahim, MD, Assiut University
- Investigators
- Abdelrady S Ibrahim, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629573
- Sponsor's protocol ID
- IRB0000871248
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Yu J, Yang F, Zhao L, Ma L, Zhang H, Chen X, Ma H. Effect of anesthetic technique on serum vascular endothelial growth factor C and prostaglandin E2 levels in women undergoing surgery for uterine leiomyomas. J Int Med Res. 2020 Apr;48(4):300060520918420. doi: 10.1177/0300060520918420.
PubMed 32314939
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Anesthesia and Myomectomy-Associated Blood Loss: A Prospective Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04629573
- Acronym / sponsor ID
- IRB0000871248
- Conditions
- Epidural; Anesthesia, Headache
- Keywords
- Epidural anesthesia, Myomectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 16 Nov 2020 (actual)
- 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.
This is a prospective study for abdominal myomectomies performed from June 2012 to June 2019 by a single surgeon in a tertiary care referral hospital. Large uterine myoma was defined as the estimated diameter of dominant myoma equal to or larger than 10 cm by sonography. Demographics, diagnosis, perioperative variables, operative outcomes and complications were recorded. The Intraoperative anesthetic management, blood and blood products transfusion, and total volume of blood loss, as well as postoperative follow-up, were reviewed for each patient.
Detailed description
Randomization and Blinding: To allow randomization, researchers prepared the management protocol for each group and sealed one protocol per envelope with a computer-generated number assigned prior to study initiation. Randomization was performed by picking the numbered study envelopes sequentially and opened before induction of anesthesia by the anesthesia doctor and managing the participant based on the enclosed protocol. The study will not be double-blinded, as it is impossible to blind the health care workers and women involved for the strategy to which the woman is allocated.
Interventions Anesthesia technique: On arrival to the operative theatre, an 18 gauge IV catheter was inserted and 500 ml of NaCl (0.9%) was infused, 1 mg midazolam was administered iv as premedication. Patients were monitored with continuous electrocardiography and pulse oximetry and intermittent non-invasive blood pressure measurements every 5 min.
Lumbar epidural: Epidural procedure was performed by attending anesthesiologists who had completed at least 50 epidural procedures during their training. Patient was placed in the sitting position, the skin over the lumbar area was cleaned and a sterile technique was observed throughout the procedure. Skin and subcutaneous tissue were infiltrated with 1% lidocaine 2 mL at the intended site of epidural placement (L2-3 or L3-4 interspace). The lumbar epidural space was then located, using a midline approach with an 18 gauge Tuohy epidural needle via a loss of resistance technique with 2 mL of saline, 20 gauge epidural catheter was placed in each patient. We deliver an initial bolus of 20 ml bupivacaine 0.5% plus 100 mcg Fentanyl, followed by continuous infusion of bupivacaine 0.5% plus 1mcg/ml Fentanyl (3-5 ml/hr.).
General anesthesia: Anesthesia was initiated with IV fentanyl 1 µg/kg, propofol 2 mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation. After tracheal intubation, anesthesia was maintained with sevoflurane in O2 and air (FiO2 of 0.5), cisatracurium 1µg/kg/min and fentanyl 0.5 µg/ kg /h were infused. Volume-Controlled ventilation was performed in all patients. Cisatracurium and fentanyl infusion was stopped at the end of surgery, neuromuscular blockade was reversed, and the patient was extubated and send to post-anesthesia care unit.
Myomectomy: Abdominal myomectomy was performed in the standard conventional fashion. A single surgeon handled all the surgical procedures. The myomectomy was performed by enucleating the fibroid and closing the uterine defect in multiple layers. The use of energy devices, suture type, and adhesion barriers were at the discretion of the surgeon.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Lumber EpiduralEpidural Anesthesia |
| Group 2 | Active comparator | Procedure: General anesthesiaGeneral Anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women over 18 years old
- American Society of Anesthesiologist (ASA) I and II
- Undergoing myomectomy for treatment of large uterine leiomyomas with a minimum diameter of 10 cm
Key exclusion criteria (3 listed)
- Patients with previous uterine surgery (myomectomy, cesarean delivery)
- Coagulopathy or other bleeding diathesis
- Severe anemia (Hb under 5.0 g/dl)
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 |
|---|---|---|
| Lumber EpiduralEpidural procedure was performed by attending anesthesiologists who had completed at least 50 epidural procedures during their training. Patient was placed in the sitting position, the skin over the lumbar area was cleaned and a sterile technique was observed throughout the procedure. Skin and subcutaneous tissue were infiltrated with 1% lidocaine 2 mL at the intended site of epidural placement (L2-3 or L3-4 interspace). The lumbar epidural space was then located, using a midline approach with an 18 gauge Tuohy epidural needle via a loss of resistance technique with 2 mL of saline, 20 gauge epidural catheter was placed in each patient. We deliver an initial bolus of 20 ml bupivacaine 0.5% plus 100 mcg Fentanyl, followed by continuous infusion of bupivacaine 0.5% plus 1mcg/ml Fentanyl (3-5 ml/hr.). | Procedure or surgery | Group 1 |
| General anesthesiaAnesthesia was initiated with IV fentanyl 1 µg/kg, propofol 2 mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation. After tracheal intubation, anesthesia was maintained with sevoflurane in O2 and air (FiO2 of 0.5), cisatracurium 1µg/kg/min and fentanyl 0.5 µg/ kg /h were infused. Volume-Controlled ventilation was performed in all patients. Cisatracurium and fentanyl infusion was stopped at the end of surgery, neuromuscular blockade was reversed, and the patient was extubated and send to post-anesthesia care unit. | Procedure or surgery | Group 2 |
Primary outcome
Blood loss
Time frame: 24 hours
Intraoperative blood loss
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 16 Nov 2020.
- Results publication: PubMed 32314939Zhang Y, Yu J, Yang F, Zhao L, Ma L, Zhang H, Chen X, Ma H. Effect of anesthetic technique on serum vascular endothelial growth factor C and prostaglandin E2 levels in women undergoing surgery for uterine leiomyomas. J Int Med Res. 2020 Apr;48(4):300060520918420. doi: 10.1177/0300060520918420.
- 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.
Abdelrady S Ibrahim principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumber Epidural and General anesthesia in people with Epidural; Anesthesia, Headache, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 3 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 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Blood loss (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04629573, which also lists 1 linked publication.
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 16 Nov 2020.