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

NCT05408052 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/292
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

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

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

  intraoperative period

Secondary Outcomes (1)

• Our secondary aim is to compare onset time

  intraoperative period

Study Arms (2)

Standard Epidural

ACTIVE COMPARATOR

Standard epidural technic will be applied before the anesthesia induction for perioperative analgesia

Procedure: Standart Epidural

Dural Puncture Epidural (DPE)

ACTIVE COMPARATOR

Dural Puncture Epidural technic will be applied before the anesthesia induction for perioperative analgesia

Procedure: Dural Puncture Epidural (DPE)

Interventions

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.

Dural Puncture Epidural (DPE)

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.

Standard Epidural

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Ayşenur Dostbil

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 7, 2022
• Study Start: August 15, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

TU (1)