Clinical trial NCT06461832: The Impact of the Anaesthetic Technique Employed on the Quality of Recovery in Patients Undergoing Hysterectomy Surgery.
Official title: Comparison of Combined Spinal-Epidural Anesthesia and General Anesthesia with Epidural Catheter for Elective Hysterectomy: Anesthetic and Analgesic Outcomes, Patient and Surgeon Satisfaction: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Analgesia
Acute Pain
Keywords: quality of recovery-15
opioid consumption
acute pain scores
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included female patients scheduled for hysterectomy.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The Quality of Recovery (QoR-40) score in the first 24 hours after surgery
timeFrame: postoperative 24 hours
measure: A comparison of the difference in recovery quality scores between patients at the preoperative and postoperative 24th hour.
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: Opioid consumption in the first 24 hours after surgery
timeFrame: postoperative 24 hours
measure: The incidences of post-operative nausea and vomiting (PONV)
timeFrame: postoperative 24 hours
measure: NRS Score
timeFrame: postoperative 24 hours
measure: Time to first mobilization
timeFrame: Up to 24 hours after surgery.
measure: Time to discharge
timeFrame: Trough hospital stay, an average of 1 week
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsung Training and Research Hospital
Study officials:
affiliation: Samsung Training and Research Hospital
name: Mehmet Gökhan Taflan
role: STUDY_DIRECTOR
References: