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Epidural Anesthesia and Myomectomy Associated Bleeding

Primary Purpose

Epidural; Anesthesia, Headache

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lumber Epidural
General anesthesia
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epidural; Anesthesia, Headache focused on measuring Epidural anesthesia, Myomectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria

  • 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

Exclusion Criteria:

  • Patients with previous uterine surgery (myomectomy, cesarean delivery)
  • Coagulopathy or other bleeding diathesis
  • Severe anemia (Hb under 5.0 g/dl)

Sites / Locations

  • Assiut university faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Epidural Anesthesia

General Anesthesia

Outcomes

Primary Outcome Measures

Blood loss
Intraoperative blood loss

Secondary Outcome Measures

Full Information

First Posted
November 10, 2020
Last Updated
November 10, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04629573
Brief Title
Epidural Anesthesia and Myomectomy Associated Bleeding
Official Title
Epidural Anesthesia and Myomectomy-Associated Blood Loss: A Prospective Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidural; Anesthesia, Headache
Keywords
Epidural anesthesia, Myomectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Epidural Anesthesia
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
General Anesthesia
Intervention Type
Procedure
Intervention Name(s)
Lumber Epidural
Intervention Description
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.).
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood loss
Description
Intraoperative blood loss
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 Exclusion Criteria: Patients with previous uterine surgery (myomectomy, cesarean delivery) Coagulopathy or other bleeding diathesis Severe anemia (Hb under 5.0 g/dl)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrady S Ibrahim
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university faculty of medicine
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32314939
Citation
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.
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Epidural Anesthesia and Myomectomy Associated Bleeding

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