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NCT Number: NCT06461832

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

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.

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Key information

Conditions

Anesthesia Acute Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Samsung Training and Research Hospital

Samsun, 55060, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: The epidural catheter and general anesthesia group

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.

Other names: The combined spinal epidural anesthesia group

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Opioid consumption in the first 24 hours after surgery

    Time frame: 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.

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

    Time frame: 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)

  3. NRS Score

    Time frame: 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.

  4. Time to first mobilization

    Time frame: Up to 24 hours after surgery.

    The patients first mobilization time after the operation will be recorded.

  5. Time to discharge

    Time frame: Trough hospital stay, an average of 1 week

    he length of hospital stay will be recorded.

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2024
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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