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

Primary Purpose

Analgesia

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Dural Puncture Epidural (DPE)

Standart Epidural

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Atatürk UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Standard Epidural

Dural Puncture Epidural (DPE)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Our secondary aim is to compare onset time

Full Information

NCT ID

NCT05408052

First Posted

May 31, 2022

Last Updated

December 1, 2022

Sponsor

Ataturk University

1. Study Identification

Unique Protocol Identification Number

NCT05408052

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 15, 2022 (Actual)

Primary Completion Date

June 1, 2023 (Anticipated)

Study Completion Date

July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Epidural

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dural Puncture Epidural (DPE)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Dural Puncture Epidural (DPE)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Standart Epidural

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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

Time Frame

intraoperative period

Secondary Outcome Measure Information:

Title

Our secondary aim is to compare onset time

Description

Our secondary aim is to compare onset time

Time Frame

intraoperative period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ayşenur Dostbil

Phone

+905333677796

adostbil@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ayşenur Dostbil

Organizational Affiliation

Ataturk University

Official's Role

Study Director

Facility Information:

Facility Name

Atatürk University

City

Erzurum

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aysenur Dostbil

12. IPD Sharing Statement

Learn more about this trial

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

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