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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06461832
• Other study ID #: KSEGAEMT2024
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Samsun University
• Contact: Mehmet Gökhan Taflan
• Phone: 05352114070
• Email: drmehmettaflan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The research was designed as a prospective observational study. It is not the intention of the researchers participating in the study to administer any medication to the patients. The examination of patient records will result in the creation of two groups, differentiated according to the anesthesia method applied. Group 1 will include patients who underwent general anesthesia with an epidural catheter, while Group 2 will consist of patients who received spinal anesthesia with an epidural catheter. The quality of patient inclusion in the study will be evaluated using a 15-question scale in both the preoperative and postoperative periods.

In the course of our research, we will employ the Quality of Recovery 15-item scale (QoR-15), which comprises 15 questions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Anesthesia

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Samsung Training and Research Hospital	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Opioid consumption in the first 24 hours after surgery	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.	postoperative 24 hours
Secondary	The incidences of post-operative nausea and vomiting (PONV)	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)	postoperative 24 hours
Secondary	NRS Score	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.	postoperative 24 hours
Secondary	Time to first mobilization	The patients first mobilization time after the operation will be recorded.	Up to 24 hours after surgery.
Secondary	Time to discharge	he length of hospital stay will be recorded.	Trough hospital stay, an average of 1 week