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

Completed

• Conditions: Acute Pain; Anesthesia; Analgesia
• Interventions: Procedure: Group 1; Procedure: Group 2

• Registration Number: NCT06461832
• Lead Sponsor: Samsun University

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.

Detailed Description

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).

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-17
• Status Verified: 2025-02
• Primary Completion: 2025-02-24
• Study Completion: 2025-02-24
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Group 1	Patients who received general anesthesia and an epidural catheter.
Group 2	Group 2	Patients who received spinal anesthesia and an epidural catheter.

Primary Outcome Measures

Name	Time	Method
A comparison of the difference in recovery quality scores between patients at the preoperative and postoperative 24th hour.	postoperative 24 hours	The difference between the patients' preoperative QoR-15 score and the QoR-15 score measured at the 24th hour postoperatively will be evaluated.
The Quality of Recovery (QoR-40) score in the first 24 hours after surgery	postoperative 24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Opioid consumption in the first 24 hours after surgery	postoperative 24 hours	Opioid consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score ≥3.
NRS Score	postoperative 24 hours	The Numerical Rating Scale (NRS) is a frequently utilized pain screening instrument for the objective assessment of the current intensity of pain, employing a scale of 0-10. The scale ranges from zero, which represents the absence of pain, to 10, which represents the worst pain imaginable. The postoperative NRS score will be evaluated at the following time points: the first, third, sixth, twelfth, and 24th hours.
The incidences of post-operative nausea and vomiting (PONV)	postoperative 24 hours	Post-operative nausea and vomiting (PONV) will be evaluated with a verbal descriptive scale.; (0 = None at all, 1 = Mild nausea, 2 = Moderate nausea, 3 = Vomiting once, 4 = Vomiting more than once)
Time to first mobilization	Up to 24 hours after surgery.	The patients first mobilization time after the operation will be recorded.
Time to discharge	Trough hospital stay, an average of 1 week	he length of hospital stay will be recorded.

Trial Locations

Locations (1)

Samsung Training and Research Hospital; 🇹🇷 Samsun, Turkey