The Impact of the Anaesthetic Technique Employed on the Quality of Recovery in Patients Undergoing Hysterectomy Surgery.

NCT ID: NCT06461832

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-02-24

Brief Summary

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The objective of this study is to evaluate the results of different anesthesia methods (general anesthesia with epidural catheter application and spinal anesthesia with epidural catheter application) applied in elective hysterectomy surgeries performed in our hospital. The aim is to compare the advantages of both methods.

Detailed Description

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The study was designed as a prospective observational study. The researchers participating in the study were not involved in administering any medications to the patients. A review of the patient records will result in the creation of two differentiated groups according to the anesthesia method administered: Group 1 will include patients who underwent general anesthesia with an epidural catheter, while Group 2 will include patients who underwent spinal anesthesia with an epidural catheter. The quality of recovery score will be evaluated using a 15-question scale both preoperatively and postoperatively. The researchers will evaluate quality of recovery using the 15-item Quality of Recovery scale (QoR-15).

Conditions

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Anesthesia Analgesia Acute Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients who received general anesthesia and an epidural catheter.

Group 1

Intervention Type PROCEDURE

In patients undergoing a hysterectomy, an epidural catheter is placed via the L3-4 or L4-5 spinal space, followed by the application of a standardized general anesthesia protocol.

Group 2

Patients who received spinal anesthesia and an epidural catheter.

Group 2

Intervention Type PROCEDURE

In patients undergoing hysterectomy, 15-20 mg of heavy bupivacaine is injected into the intrathecal area via the L3-4 or L4-5 spinal space, using a spinal needle. Following the removal of the spinal needle, an epidural catheter is then placed through the same opening.

Interventions

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Group 1

In patients undergoing a hysterectomy, an epidural catheter is placed via the L3-4 or L4-5 spinal space, followed by the application of a standardized general anesthesia protocol.

Intervention Type PROCEDURE

Group 2

In patients undergoing hysterectomy, 15-20 mg of heavy bupivacaine is injected into the intrathecal area via the L3-4 or L4-5 spinal space, using a spinal needle. Following the removal of the spinal needle, an epidural catheter is then placed through the same opening.

Intervention Type PROCEDURE

Other Intervention Names

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The epidural catheter and general anesthesia group The combined spinal epidural anesthesia group

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for elective hysterectomy
* Patients with The American Society of Anaesthesiologists (ASA) physical status class1-2-3
* Those who are literate enough to answer the compilation quality of recovery score (QoR-15) questionnaire

Exclusion Criteria

* Patients with contraindications for neuraxial anesthesia
* Patients with The American Society of Anaesthesiologists (ASA) physical status score above 3
* The presence of another malignant neoplasm, other than the indication for hysterectomy,
* Patients with substance abuse disorders, including alcohol and drug addiction
* Patients who do not consent to or desire to be included in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsun University

OTHER

Sponsor Role lead

Responsible Party

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MEHMET GÖKHAN TAFLAN

Specialist Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Gökhan Taflan

Role: STUDY_DIRECTOR

Samsung Training and Research Hospital

Locations

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Samsung Training and Research Hospital

Samsun, Samsun, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KSEGAEMT2024

Identifier Type: -

Identifier Source: org_study_id

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