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

NCT06461832 | Completed

• 1 other identifier: KSEGAEMT2024
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Analgesia; Acute Pain

Keywords

quality of recovery-15; opioid consumption; acute pain scores

Outcome Measures

Primary Outcomes (2)

• The Quality of Recovery (QoR-40) score in the first 24 hours after surgery

  The recovery quality of patients will be assessed with the Quality of Recovery Score-15 (QoR-15), which will be administered at the 24th hour postoperatively. The QoR-15 is a questionnaire comprising 15 items, with each item scored on a scale of 0 to 10. The total score on the QoR-15 ranges between 0 and 150.

  postoperative 24 hours

• A comparison of the difference in recovery quality scores between patients at the preoperative and postoperative 24th hour.

  The difference between the patients' preoperative QoR-15 score and the QoR-15 score measured at the 24th hour postoperatively will be evaluated.

  postoperative 24 hours

Secondary Outcomes (5)

• Opioid consumption in the first 24 hours after surgery

  postoperative 24 hours

• The incidences of post-operative nausea and vomiting (PONV)

  postoperative 24 hours

• NRS Score

  postoperative 24 hours

• Time to first mobilization

  Up to 24 hours after surgery.

• Time to discharge

  Trough hospital stay, an average of 1 week

Study Arms (2)

Group 1

Patients who received general anesthesia and an epidural catheter.

Procedure: Group 1

Group 2

Patients who received spinal anesthesia and an epidural catheter.

Procedure: Group 2

Interventions

Group 1 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.

Also known as: The epidural catheter and general anesthesia group

Group 1

Group 2 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.

Also known as: The combined spinal epidural anesthesia group

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: As our sample group is to undergo hysterectomy surgery, the study will include only female patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study included female patients scheduled for hysterectomy.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsung Training and Research Hospital

Samsun, Samsun, 55060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Acute Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Mehmet Gökhan Taflan

  Samsung Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: April 1, 2024
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

TU (1)