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Completed

NCT Number: NCT04629573

Epidural Anesthesia and Myomectomy Associated Bleeding

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lumber Epidural

Procedure

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

Procedure

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 outcomes

  1. Blood loss

    Time frame: 24 hours

    Intraoperative blood loss

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Epidural Anesthesia and Myomectomy-Associated Blood Loss: A Prospective Randomised Controlled Study

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2020
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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