AnesthesiaNCT06461832
The Impact of the Anaesthetic Technique Employed on the Quality of Recovery in Patients Undergoing Hysterectomy Surgery.
An observational study of Anesthesia and Analgesia, run by Samsun University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia, Analgesia, Acute Pain
- What is being tested?
- Group 1 and Group 2
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 24 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study included female patients scheduled for hysterectomy.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsung Training and Research Hospital
Samsun, Samsun, 55060
About this study
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
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.
Read the 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).
- Conditions
- Anesthesia, Analgesia, Acute Pain
- Being tested
- Group 1, Group 2
- Keywords
- quality of recovery-15, opioid consumption, acute pain scores
- Medical subject headings
- Agnosia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Procedure or surgery
Also called The epidural catheter and general anesthesia group
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 2Procedure or surgery
Also called The combined spinal epidural anesthesia group
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients who received general anesthesia and an epidural catheter. Receives: Procedure: Group 1 | |
| Group 2 | Patients who received spinal anesthesia and an epidural catheter. Receives: Procedure: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative 24 hours
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.
Measured: postoperative 24 hours
Secondary outcomes (5)
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.
Measured: postoperative 24 hours
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)
Measured: postoperative 24 hours
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.
Measured: postoperative 24 hours
Time to first mobilization
The patients first mobilization time after the operation will be recorded.
Measured: Up to 24 hours after surgery.
Time to discharge
he length of hospital stay will be recorded.
Measured: Trough hospital stay, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Apr 2024
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MEHMET GÖKHAN TAFLAN, Samsun University
- Investigators
- Mehmet Gökhan Taflan, Study director, Samsung Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461832
- Sponsor's protocol ID
- KSEGAEMT2024
- Status last verified
- Feb 2025
- First submitted
- 11 Jun 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06461832
- Acronym / sponsor ID
- KSEGAEMT2024
- Conditions
- Anesthesia, Analgesia, Acute Pain
- Keywords
- quality of recovery-15, opioid consumption, acute pain scores
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Group 1Patients who received general anesthesia and an epidural catheter. |
| Group 2 | – | Procedure: Group 2Patients who received spinal anesthesia and an epidural catheter. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included female patients scheduled for hysterectomy.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1Also: The epidural catheter and general anesthesia groupIn 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. | Procedure or surgery | Group 1 |
| Group 2Also: The combined spinal epidural anesthesia groupIn 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. | Procedure or surgery | Group 2 |
Primary outcome
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.
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.
5 secondary outcomes
Opioid consumption in the first 24 hours after surgery
Time frame: postoperative 24 hours
The incidences of post-operative nausea and vomiting (PONV)
Time frame: postoperative 24 hours
NRS Score
Time frame: postoperative 24 hours
Time to first mobilization
Time frame: Up to 24 hours after surgery.
Time to discharge
Time frame: Trough hospital stay, an average of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Gökhan Taflan study director
Samsung Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Analgesia, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Quality of Recovery (QoR-40) score in the first 24 hours after surgery (time frame: postoperative 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.