Quality of RecoveryNCT05181358
Relationship Between Analgesia Techniques and Post-cesarean Recovery Quality
An observational study of Quality of Recovery and Cesarean Section, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The question remains whether the patients in whom USG-guided regional anesthesia and analgesia techniques are applied have a better recovery score than subarachnoid morphine administration, which is considered the gold standard. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Recovery, Cesarean Section
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2022to 26 Dec 2022
- 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 47 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Term obstetric patients who underwent elective cesarean section under spinal anesthesia
Who may be able to join
- Term obstetric patients aged 18-47 years who underwent elective cesarean section under spinal anesthesia and applied regional anesthesia techniques such as lateral TAP, posterior-TAP, QL, ESP, and TFD blocks or subarachnoid morphine.
Who cannot join
- Patients with psychiatric disorders
- Patients requiring emergency cesarean section.
- Patients with additional obstetric pathology (such as placenta previa, preeclampsia, DM)
- The need for intensive care in the mother or newborn at the end of the birth.
- Patients who have undergone general anesthesia.
- Preterm pregnants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Different Postoperative Analgesia Techniques and Post-cesarean Quality of Recovery; Prospective Observational Study
The question remains whether the patients in whom USG-guided regional anesthesia and analgesia techniques are applied have a better recovery score than subarachnoid morphine administration, which is considered the gold standard. The primary aim of this study is to evaluate the quality of recovery score using the Obstetric Recovery Quality Score-ObsQoR-10 questionnaire experienced by the patients who underwent elective cesarean section and compare the results of different regional anesthesia techniques with subarachnoid morphine.
Read the detailed description
National and international guidelines, hospital protocols, the anesthesiologist's experience, and the patient's decision play a role in selecting the technique used for postoperative analgesia after cesarean section. The quality of recovery score experienced following elective cesarean section in a total of 180 patients over one year (December 31, 2021-2022) who applied subarachnoid morphine, lateral TAP block, posterior-TAP block, QL block, ESP block, and TFD block (30 patients for each technique) will be evaluated with the ObsQoR-10 questionnaire 24 hours after delivery. The regional anesthesia techniques information applied to the patients will be obtained from the patient file. Researchers will not perform any interventional procedure, and any randomization will not be applied. After the data collection process for the study is completed, ObsQoR-10 will be compared statistically. The secondary aims of this study are to compare the cases in terms of postoperative analgesia and antiemetic requirements, first food intake and standing up without support, and patient satisfaction.
- Conditions
- Quality of Recovery, Cesarean Section
- Keywords
- Quality of recovery, ObsQoR-10, regional analgesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric Quality of Recovery
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
Measured: The first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start24 Jan 2022
- Primary completion26 Dec 2022
- Study completion26 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of RecoveryStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181358
- Sponsor's protocol ID
- ObsQoR-10 PNB
- Status last verified
- Jan 2023
- First submitted
- 19 Dec 2021
- Last updated
- 26 Jan 2023
- 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 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Different Postoperative Analgesia Techniques and Post-cesarean Quality of Recovery; Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05181358
- Acronym / sponsor ID
- ObsQoR-10 PNB
- Conditions
- Quality of Recovery, Cesarean Section
- Keywords
- Quality of recovery, ObsQoR-10, regional analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 26 Dec 2022 (actual)
- Study completion
- 26 Dec 2022 (actual)
- First posted
- 6 Jan 2022 (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 question remains whether the patients in whom USG-guided regional anesthesia and analgesia techniques are applied have a better recovery score than subarachnoid morphine administration, which is considered the gold standard. The primary aim of this study is to evaluate the quality of recovery score using the Obstetric Recovery Quality Score-ObsQoR-10 questionnaire experienced by the patients who underwent elective cesarean section and compare the results of different regional anesthesia techniques with subarachnoid morphine.
Detailed description
National and international guidelines, hospital protocols, the anesthesiologist's experience, and the patient's decision play a role in selecting the technique used for postoperative analgesia after cesarean section. The quality of recovery score experienced following elective cesarean section in a total of 180 patients over one year (December 31, 2021-2022) who applied subarachnoid morphine, lateral TAP block, posterior-TAP block, QL block, ESP block, and TFD block (30 patients for each technique) will be evaluated with the ObsQoR-10 questionnaire 24 hours after delivery. The regional anesthesia techniques information applied to the patients will be obtained from the patient file. Researchers will not perform any interventional procedure, and any randomization will not be applied. After the data collection process for the study is completed, ObsQoR-10 will be compared statistically. The secondary aims of this study are to compare the cases in terms of postoperative analgesia and antiemetic requirements, first food intake and standing up without support, and patient satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Term obstetric patients who underwent elective cesarean section under spinal anesthesia
Key inclusion criteria (1 listed)
- Term obstetric patients aged 18-47 years who underwent elective cesarean section under spinal anesthesia and applied regional anesthesia techniques such as lateral TAP, posterior-TAP, QL, ESP, and TFD blocks or subarachnoid morphine.
Key exclusion criteria (6 listed)
- Patients with psychiatric disorders
- Patients requiring emergency cesarean section.
- Patients with additional obstetric pathology (such as placenta previa, preeclampsia, DM)
- The need for intensive care in the mother or newborn at the end of the birth.
- Patients who have undergone general anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obstetric Quality of Recovery
Time frame: The first 24 hours postoperatively
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
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 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Quality of Recovery and Cesarean Section, run by Konya Meram State Hospital 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 1 inclusion and 6 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 Jan 2023. 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?
Obstetric Quality of Recovery (time frame: The first 24 hours postoperatively). 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 Jan 2023.