Epidural Versus General Anesthesia for Laparoscopic Hysterectomy

NCT07847801 | Not Yet Recruiting

• 1 other identifier: KSH-ARKHD-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study will compare epidural anesthesia with general anesthesia in women undergoing elective laparoscopic hysterectomy. A total of 70 participants will be randomly assigned to receive either epidural anesthesia or general anesthesia. The main aim of the study is to determine whether the type of anesthesia affects respiratory function after surgery. Respiratory function will primarily be assessed using peak expiratory flow rate (PEFR) before surgery and at 2, 6, and 24 hours after surgery. The study will also compare postoperative pain, opioid consumption, respiratory and hemodynamic parameters, recovery, mobilization, and other perioperative outcomes between the two groups. The researchers aim to determine whether epidural anesthesia may provide an alternative anesthetic approach for selected patients undergoing laparoscopic hysterectomy while maintaining spontaneous breathing.

Conditions

Anesthesia for Laparoscopic Hysterectomy

Keywords

Epidural Anesthesia; General Anesthesia; Laparoscopic Hysterectomy; Postoperative Respiratory Function; Peak Expiratory Flow Rate; Postoperative Pain; Opioid Consumption

Outcome Measures

Primary Outcomes (1)

• Change in Peak Expiratory Flow Rate (PEFR)

  Peak expiratory flow rate (PEFR), measured in liters per minute (L/min), will be assessed before surgery and at 2, 6, and 24 hours after surgery. The change in PEFR from the preoperative baseline will be compared between the epidural anesthesia and general anesthesia groups

  Preoperative baseline and 2, 6, and 24 hours after surgery

Study Arms (2)

Epidural Anesthesia

EXPERIMENTAL

Participants assigned to this arm will receive epidural anesthesia via a lumbar epidural catheter. An initial dose of 10 mL of 0.5% bupivacaine with 50 mcg fentanyl will be administered, followed by incremental doses of 2-3 mL of 0.5% bupivacaine every 5 minutes as required to achieve a T4 sensory block, up to approximately 20 mL. Spontaneous ventilation will be maintained. Dexmedetomidine will be administered at 0.2 mcg/kg/h for sedation. Conversion to general anesthesia will be performed if the epidural block is inadequate, the participant cannot tolerate the procedure, or conversion is clinically required.

Procedure: epidural anesthesia

General Anesthesia

ACTIVE COMPARATOR

Participants assigned to this arm will receive standard general anesthesia. Anesthesia will be induced with propofol 2-2.5 mg/kg, fentanyl 1-2 mcg/kg, and rocuronium 0.6 mg/kg, followed by endotracheal intubation. Anesthesia will be maintained with sevoflurane and controlled mechanical ventilation, with end-tidal carbon dioxide maintained between 35 and 40 mmHg.

Procedure: General Anesthesia (GA)

Interventions

epidural anesthesia PROCEDURE

pidural anesthesia will be administered via a lumbar epidural catheter using 0.5% bupivacaine and fentanyl. Incremental epidural doses will be administered to achieve an adequate sensory block. Spontaneous ventilation will be maintained, and dexmedetomidine will be used for sedation.

Epidural Anesthesia

General Anesthesia (GA) PROCEDURE

General anesthesia will be induced with intravenous propofol, fentanyl, and rocuronium, followed by endotracheal intubation. Anesthesia will be maintained with sevoflurane and controlled mechanical ventilation.

General Anesthesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-70 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Body mass index (BMI) ≤30 kg/m²
• Scheduled for elective laparoscopic total hysterectomy
• Willing and able to provide informed consent

You may not qualify if:

• Contraindication to neuraxial anesthesia
• Severe cardiopulmonary disease
• BMI \>30 kg/m²
• Pre-existing neurological disorder
• Inability to cooperate with the study procedures
• Refusal to participate in the study

Sponsors & Collaborators

• Sabiha Başarı: lead

Study Sites (1)

Kutahya City Hospital

Kütahya, Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Epidural; Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Sabiha Başarı, MD

  Kutahya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabiha Başarı, MD

CONTACT

+905446616686; sabihabasari0@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anaesthesiology and Intensive Care Specialist

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the epidural anesthesia group or the general anesthesia group. Each participant will receive only the intervention assigned to their group.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): October 22, 2026
• Primary Completion (Estimated): October 22, 2027
• Study Completion (Estimated): October 22, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the study results and available for 5 years.
• Access Criteria: De-identified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request to the corresponding author. Requests should include a scientifically sound research proposal. Data will be shared only after review and approval of the request and in accordance with applicable ethical and data protection requirements.

Locations

TU (1)