NCT05408052

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ataturk University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Analgesia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-08-15
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2022-06-07
• Last updated: 2025-02-05

Locations

1 site across 1 country: Turkey (Türkiye)