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

Sponsor

Ataturk University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05408052

Collaborator

(none)

Enrollment

Arms

12.5

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Procedure: Dural Puncture Epidural (DPE) Procedure: Standart Epidural	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Epidural Standard epidural technic will be applied before the anesthesia induction for perioperative analgesia	Procedure: Standart Epidural 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.
Active Comparator: Dural Puncture Epidural (DPE) Dural Puncture Epidural technic will be applied before the anesthesia induction for perioperative analgesia	Procedure: Dural Puncture Epidural (DPE) 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.

Arm

Intervention/Treatment

Active Comparator: Standard Epidural

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

Procedure: Standart Epidural

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.

Active Comparator: Dural Puncture Epidural (DPE)

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

Procedure: Dural Puncture Epidural (DPE)

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.

Outcome Measures

Primary Outcome Measures

The primary outcome is to compare the total amount of epidural local anesthetics consumed during the intraoperative period [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 [intraoperative period]
Our secondary aim is to compare onset time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ataturk University

Investigators

Study Director: Ayşenur Dostbil, Ataturk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aysenur Dostbil, Clinical Professor, Ataturk University

ClinicalTrials.gov Identifier:

NCT05408052

Other Study ID Numbers:

B.30.2.ATA.0.01.00/292

First Posted:

Jun 7, 2022

Last Update Posted:

Jun 7, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Agnosia

Study Results

No Results Posted as of Jun 7, 2022