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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06461832
Enrollment
84
Registered
2024-06-17
Start date
2024-04-01
Completion date
2025-02-24
Last updated
2025-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Analgesia, Anesthesia

Keywords

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

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).

Interventions

PROCEDUREGroup 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.

PROCEDUREGroup 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.

Sponsors

Samsun University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
NRS Scorepostoperative 24 hoursThe 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.
Opioid consumption in the first 24 hours after surgerypostoperative 24 hoursOpioid 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.
Time to dischargeTrough hospital stay, an average of 1 weekhe length of hospital stay will be recorded.
Time to first mobilizationUp to 24 hours after surgery.The patients first mobilization time after the operation will be recorded.
The incidences of post-operative nausea and vomiting (PONV)postoperative 24 hoursPost-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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026