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NCT Number: NCT05408052

Comparison of Standard Epidural and Dural Puncture Epidural Analgesia in Open Gynecological Surgery Techniques

The aim of this study is to compare the effectiveness of standard epidural and dural puncture epidural analgesia techniques used under NOL guidance.

The primary aim of this study was to evaluate the effect of NOL-guided antinociception on intraoperative total local anesthetic consumption during anesthesia.

The secondary aim is to compare onset time, analgesia duration time, hemodynamic parameters, time to first postoperative analgesic requirement, and postoperative side effects.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University

Erzurum, Turkey (Türkiye)

About this study

This prospective randomized double-blind study was planned in 36 adult female patients aged 18-75 years, with ASA I-III, who underwent elective open gynecological surgery under general anesthesia with lower midline or Pfannenstiel incision after Ataturk University Medical Faculty Hospital ethics committee approval and written consent of the patients.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA I-III physical condition
  • patients aged between 18-75 years
  • elective surgeries under general anesthesia for gynecological procedures
  • lower midline or Pfannenstiel incision

Exclusion criteria

  • patients with classical contraindications to neuraxial procedures,
  • morbidly obese (body mass index > 40 kg / m2),
  • pregnant and lactating women
  • hypersensitive or allergic to local anesthetic agents,
  • abuse of drugs or alcohol in the past 6 months.
  • chronic opioid use before surgery,
  • using chronic psychoactive drugs in the 90 days before surgery,
  • patients with peripheral and central nervous system disease,
  • preoperative hemodynamic compromise (patients with irregular sinus heart rhythm and pacemaker)
  • patients using antimuscarinic, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents,
  • patients with diabetes, severe lung and significant liver disease with increased bilirubin,
  • operations that will take less than 2 hours
  • MAP >160 mmHg or <60 mmHg, heart rate >90 beats/min or <45 beats/min on the day of surgery
  • patients who do not want to participate in the study will be excluded from the study

Treatment and study plan

Dural Puncture Epidural (DPE)

Procedure

Using the 18G Tuohy needle in the sitting position, the epidural space will be determined from the L3-L4 or L4-L5 space using the loss-of-resistance method After Dural puncture will be performed using a 25G Whitacre needle from the Tuohy needle to patients in the DPE group and free CSF flow will be observed, but no medication will be applied to the subarachnoid space. Afterwards, epidural catheter will be placed and when the catheter is fixed, a test dose of 3 mL will be administered through the catheter to check for intravascular or subarachnoid catheter placement.

An epidural local anesthetic will be administered throughout the catheter for intraoperative analgesia at 0,1% (bupivacaine+fentanyl+ saline) concentration with the NoL monitor guidance.

Standart Epidural

Procedure

The neuraxial procedure will be performed in the sitting position using the 18G Tuohy needle, in the L3-L4 or L4-L5 range using the loss-of-resistance method.

The epidural catheter will be placed so that it remains 4 to 5 cm in the epidural space. After the catheter is fixed, a test dose of 3 mL will be administered through the catheter to check for intravascular or subarachnoid catheter placement.

An epidural local anesthetic will be administered throughout the catheter for intraoperative analgesia at 0,1% (bupivacaine+fentanyl+ saline) concentration with the NoL monitor guidance.

Primary outcomes

  1. The primary outcome is to compare the total amount of epidural local anesthetics consumed during the intraoperative period

    Time frame: intraoperative period

    The primary outcome is to compare the total amount of epidural local anesthetics (mg) consumed during the intraoperative period

Secondary outcomes

  1. Our secondary aim is to compare onset time

    Time frame: intraoperative period

    Our secondary aim is to compare onset time

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Comparison of the Efficiency of Standard Epidural and Dural Puncture Epidural Analgesia Techniques Guided by Nociception Level Index in Open Gynecological Surgery Under General Anesthesia: a Prospective Randomized Double-Blind Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2022
Registry last updated
Feb 5, 2025

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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