Postoperative Pain ManagementNCT07181902
Postoperative Recovery Quality After Cesarean Section: Comparing Erector Spinae and Retrolaminar Blocks Using Turkish Version of the Obstetric Quality-of-Recovery Score in a Turkish Cohort (ObsQoR-11T)
An observational study of Postoperative Pain Management, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
Study Design This retrospective observational study aims to evaluate and compare the effects of two regional anesthesia techniques, Erector Spinae Plane (ESP) block and Retrolaminar Block (RLB), on postoperative recovery quality in women undergoing elective cesarean section (CS). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Erector Spinae Plane Block (ESP) and Retrolaminar Block (RLB)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This study includes adult women undergoing elective cesarean section at Elazığ Fethi Sekin City Hospital. Participants will receive either an Erector Spinae Plane (ESP) block or a Retrolaminar Block (RLB) for postoperative analgesia and will be followed for postoperative recovery quality and pain outcomes.
Who may be able to join
- Women aged 18-45 years, scheduled for elective cesarean delivery under spinal anesthesia.
- Gestational age ≥37 weeks, singleton pregnancy.
- Undergoing either ESP or RLB for postoperative analgesia.
- ASA Physical Status II-III.
- Ability to understand and complete ObsQoR-11T questionnaire.
- Provided written informed consent prior to participation. Exclusion Criteria
Show all 15Show fewer
- Emergency cesarean delivery.
- Multiple pregnancy, preterm delivery (<37 weeks),
- Severe maternal or obstetric complications (e.g., preeclampsia, placenta previa, placenta accreta spectrum), regardless of urgency.
- BMI ≥40 kg/m²
- Significant systemic diseases (e.g., severe cardiac, respiratory, renal, or hepatic disease).
- Fetal or placental anomalies.
- History of chronic pain syndromes, opioid dependence, or long-term analgesic use.
- Neurological, psychiatric, or cognitive disorders that may interfere with pain perception or questionnaire completion.
- Patients who declined participation or did not provide informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Seçiniz, 23100
Serpil Bayındır, 05055493582, serpilbayindir@gmail.com.tr
About this study
Official title: Postoperative Recovery Quality After Cesarean Section: Comparing Erector Spinae and Retrolaminar Blocks Using Turkish Version of the Obstetric Quality-of-Recovery Score (ObsQoR-11T) in a Turkish Cohort
Study Design This retrospective observational study aims to evaluate and compare the effects of two regional anesthesia techniques, Erector Spinae Plane (ESP) block and Retrolaminar Block (RLB), on postoperative recovery quality in women undergoing elective cesarean section (CS). Postoperative pain after CS is common, particularly in the first 24-72 hours, and can affect mobility, breastfeeding, and overall well-being. Effective pain management is therefore critical for both patient comfort and maternal-infant bonding.
Participants and Methods Medical records of adult women aged 18-45 years, with a singleton pregnancy at ≥37 weeks, who underwent elective CS under spinal anesthesia in our clinic, were retrospectively reviewed. Patients who had received either ESP or RLB immediately after surgery were included. Both blocks had been performed under ultrasound guidance at the T9 level using 20 mL of 0.25% bupivacaine, according to institutional practice. Standard perioperative care and analgesia protocols were applied to all patients.
Read more
Outcomes The primary outcome was postoperative recovery quality, assessed 24 hours after surgery using the Turkish version of the Obstetric Quality-of-Recovery Score (ObsQoR-11T), a validated tool addressing physical, emotional, and functional aspects of recovery. Secondary outcomes included postoperative pain intensity (Visual Analog Scale), opioid consumption, adverse events, and patient satisfaction, as documented in patient files.
Conclusion This retrospective study will provide evidence on which block technique more effectively improves recovery quality after CS and may help optimize postoperative analgesia strategies in Turkish obstetric populations.
Read the detailed description
METHODS 1.1. Study Design and Settings
This was a retrospective, single-center observational study conducted to evaluate the effects of ESP and RLB on postoperative pain, opioid consumption, and patient satisfaction in women undergoing cesarean section. The study was carried out at Elazığ Fethi Sekin City Hospital, a tertiary care center in Elazığ, Türkiye. Medical records of eligible patients were reviewed for the analysis. The study protocol was approved by the local institutional ethics committee and conducted in accordance with the principles of the Declaration of Helsinki.
1.2. Participants
The study population consisted of adult women who had undergone elective CS at Elazığ Fethi Sekin City Hospital between [start date] and [end date].
Inclusion Criteria
Women aged 18-45 years who underwent elective CS under spinal anesthesia.
Gestational age ≥37 weeks, singleton pregnancy.
Received either ESP or RLB for postoperative analgesia, documented in anesthesia records.
ASA Physical Status II-III.
Completion of ObsQoR-11T questionnaire at 24 hours postoperatively.
Exclusion Criteria
Emergency cesarean delivery.
Multiple pregnancy or preterm delivery (<37 weeks).
Severe maternal or obstetric complications (e.g., preeclampsia, placenta previa, placenta accreta spectrum).
BMI ≥40 kg/m².
Significant systemic disease (e.g., severe cardiac, respiratory, renal, or hepatic disease).
Fetal or placental anomalies.
History of chronic pain syndromes, opioid dependence, or long-term analgesic use.
Neurological, psychiatric, or cognitive disorders interfering with pain perception or questionnaire completion.
Missing or incomplete data in the medical records.
1.3. Protocol and Outcome Measures
Anesthesia and Postoperative Analgesia All patients had received a standardized spinal anesthesia protocol. During surgery, patients had been positioned supine with a 15° left tilt and given oxygen at 4 L/min via face mask. Adequate sensory block at the T4-T6 level had been confirmed before the CS procedure began.
Approximately 30 minutes before the end of surgery, intravenous 1 g paracetamol and 50 mg dexketoprofen had been administered as part of multimodal postoperative analgesia. Before recovery, ESP or RLB was performed at the T9 level under ultrasound guidance.
Patients were classified into two groups according to the block technique documented in anesthesia charts:
ESP Group: Bilateral ESP block at T9 with 20 mL of 0.25% bupivacaine per side.
RLB Group: Bilateral RLB at T9 with 20 mL of 0.25% bupivacaine per side.
All blocks had been performed by experienced anesthesiologists trained in ultrasound-guided techniques. Postoperatively, patients were monitored in the recovery unit and transferred to the postpartum ward once stable (Modified Aldrete score ≥9).
Surgical Technique Only patients whose records documented a standardized surgical technique were included. All elective CS operations had been performed using a Pfannenstiel skin incision and a lower-segment transverse uterine incision. Uterine closure had been performed with a single layer of absorbable sutures.
Primary Outcome The primary outcome was postoperative recovery quality, assessed at 24 hours using the ObsQoR-11T score recorded in patient files.
Secondary Outcomes
Demographic and clinical characteristics (age, BMI, ASA status, comorbidities, obstetric history).
Intraoperative data: duration of surgery and anesthesia.
Postoperative analgesic requirements: time to first rescue analgesic, total analgesic consumption within 24 hours.
Pain intensity (VAS at rest and on coughing at 1, 6, 12, and 24 hours).
Adverse events (nausea, vomiting, hypotension, bradycardia, block-related complications).
Patient satisfaction scores as documented in follow-up notes.
1.4. Sample Size
As this was a retrospective study, no prior sample size calculation was performed. All patients who met the inclusion criteria during the study period were included in the analysis.
- Conditions
- Postoperative Pain Management
- Being tested
- Erector Spinae Plane Block (ESP), Retrolaminar Block (RLB)
- Keywords
- Cesarean Section, Retrolaminar Block, ObsQoR-11T, Erector Spinae Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block (ESP)Procedure or surgery
Ultrasound-guided ESP block performed immediately after cesarean section at T9 level using 20 mL of 0.25% bupivacaine. Standard perioperative care and analgesia protocols are applied.
Retrolaminar Block (RLB)Procedure or surgery
Ultrasound-guided Retrolaminar Block performed immediately after cesarean section at T9 level using 20 mL of 0.25% bupivacaine. Standard perioperative care and analgesia protocols are applied.
| Study group | Role | What they receive |
|---|---|---|
| ESP Group - Erector Spinae Plane Block | Patients receiving ultrasound-guided Erector Spinae Plane (ESP) block immediately after cesarean section under spinal anesthesia. The block is performed at T9 level using 20 mL of 0.25% bupivacaine. Standard perioperative care and analgesia protocols are applied to all participants. Postoperative recovery quality, pain scores, opioid consumption, and adverse events are recorded. Receives: Procedure: Erector Spinae Plane Block (ESP) | |
| RLB Group - Retrolaminar Block | Patients receiving ultrasound-guided Retrolaminar Block (RLB) immediately after cesarean section under spinal anesthesia. The block is performed at T9 level using 20 mL of 0.25% bupivacaine. Standard perioperative care and analgesia protocols are applied. Postoperative recovery quality, pain scores, opioid consumption, and adverse events are recorded. Receives: Procedure: Retrolaminar Block (RLB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Recovery Quality After Cesarean Section (ObsQoR-11T)
The primary outcome is the quality of postoperative recovery, assessed using the Turkish version of the Obstetric Quality-of-Recovery Score (ObsQoR-11T). This validated questionnaire evaluates multidimensional aspects of recovery, including patient comfort, physical and emotional well-being, and functional status. Scores are recorded 24 hours after cesarean section to compare recovery between ESP and RLB groups.
Measured: 24 hours postoperatively
Secondary outcomes (2)
Postoperative Pain Intensity (Visual Analog Scale)
Pain intensity at rest and during coughing is assessed using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst imaginable pain) at 1, 6, 12, and 24 hours postoperatively in both ESP and RLB groups.
Measured: 1, 6, 12, and 24 hours postoperatively
Total Analgesic Consumption
Total postoperative analgesic consumption, including opioids and non-opioid medications, is recorded during the first 24 hours after cesarean section to compare ESP and RLB groups.
Measured: 0-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies 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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Bayındır, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181902
- Sponsor's protocol ID
- FSCH-SB-2024/09CSRLB
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Recovery Quality After Cesarean Section: Comparing Erector Spinae and Retrolaminar Blocks Using Turkish Version of the Obstetric Quality-of-Recovery Score (ObsQoR-11T) in a Turkish Cohort
- ClinicalTrials.gov ID
- NCT07181902
- Acronym / sponsor ID
- FSCH-SB-2024/09CSRLB
- Conditions
- Postoperative Pain Management
- Keywords
- Cesarean Section, Retrolaminar Block, ObsQoR-11T, Erector Spinae Plane Block
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 18 Sep 2025 (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.
Study Design This retrospective observational study aims to evaluate and compare the effects of two regional anesthesia techniques, Erector Spinae Plane (ESP) block and Retrolaminar Block (RLB), on postoperative recovery quality in women undergoing elective cesarean section (CS). Postoperative pain after CS is common, particularly in the first 24-72 hours, and can affect mobility, breastfeeding, and overall well-being. Effective pain management is therefore critical for both patient comfort and maternal-infant bonding.
Participants and Methods Medical records of adult women aged 18-45 years, with a singleton pregnancy at ≥37 weeks, who underwent elective CS under spinal anesthesia in our clinic, were retrospectively reviewed. Patients who had received either ESP or RLB immediately after surgery were included. Both blocks had been performed under ultrasound guidance at the T9 level using 20 mL of 0.25% bupivacaine, according to institutional practice. Standard perioperative care and analgesia protocols were applied to all patients.
Outcomes The primary outcome was postoperative recovery quality, assessed 24 hours after surgery using the Turkish version of the Obstetric Quality-of-Recovery Score (ObsQoR-11T), a validated tool addressing physical, emotional, and functional aspects of recovery. Secondary outcomes included postoperative pain intensity (Visual Analog Scale), opioid consumption, adverse events, and patient satisfaction, as documented in patient files.
Conclusion This retrospective study will provide evidence on which block technique more effectively improves recovery quality after CS and may help optimize postoperative analgesia strategies in Turkish obstetric populations.
Detailed description
METHODS 1.1. Study Design and Settings
This was a retrospective, single-center observational study conducted to evaluate the effects of ESP and RLB on postoperative pain, opioid consumption, and patient satisfaction in women undergoing cesarean section. The study was carried out at Elazığ Fethi Sekin City Hospital, a tertiary care center in Elazığ, Türkiye. Medical records of eligible patients were reviewed for the analysis. The study protocol was approved by the local institutional ethics committee and conducted in accordance with the principles of the Declaration of Helsinki.
1.2. Participants
The study population consisted of adult women who had undergone elective CS at Elazığ Fethi Sekin City Hospital between [start date] and [end date].
Inclusion Criteria
Women aged 18-45 years who underwent elective CS under spinal anesthesia.
Gestational age ≥37 weeks, singleton pregnancy.
Received either ESP or RLB for postoperative analgesia, documented in anesthesia records.
ASA Physical Status II-III.
Completion of ObsQoR-11T questionnaire at 24 hours postoperatively.
Exclusion Criteria
Emergency cesarean delivery.
Multiple pregnancy or preterm delivery (<37 weeks).
Severe maternal or obstetric complications (e.g., preeclampsia, placenta previa, placenta accreta spectrum).
BMI ≥40 kg/m².
Significant systemic disease (e.g., severe cardiac, respiratory, renal, or hepatic disease).
Fetal or placental anomalies.
History of chronic pain syndromes, opioid dependence, or long-term analgesic use.
Neurological, psychiatric, or cognitive disorders interfering with pain perception or questionnaire completion.
Missing or incomplete data in the medical records.
1.3. Protocol and Outcome Measures
Anesthesia and Postoperative Analgesia All patients had received a standardized spinal anesthesia protocol. During surgery, patients had been positioned supine with a 15° left tilt and given oxygen at 4 L/min via face mask. Adequate sensory block at the T4-T6 level had been confirmed before the CS procedure began.
Approximately 30 minutes before the end of surgery, intravenous 1 g paracetamol and 50 mg dexketoprofen had been administered as part of multimodal postoperative analgesia. Before recovery, ESP or RLB was performed at the T9 level under ultrasound guidance.
Patients were classified into two groups according to the block technique documented in anesthesia charts:
ESP Group: Bilateral ESP block at T9 with 20 mL of 0.25% bupivacaine per side.
RLB Group: Bilateral RLB at T9 with 20 mL of 0.25% bupivacaine per side.
All blocks had been performed by experienced anesthesiologists trained in ultrasound-guided techniques. Postoperatively, patients were monitored in the recovery unit and transferred to the postpartum ward once stable (Modified Aldrete score ≥9).
Surgical Technique Only patients whose records documented a standardized surgical technique were included. All elective CS operations had been performed using a Pfannenstiel skin incision and a lower-segment transverse uterine incision. Uterine closure had been performed with a single layer of absorbable sutures.
Primary Outcome The primary outcome was postoperative recovery quality, assessed at 24 hours using the ObsQoR-11T score recorded in patient files.
Secondary Outcomes
Demographic and clinical characteristics (age, BMI, ASA status, comorbidities, obstetric history).
Intraoperative data: duration of surgery and anesthesia.
Postoperative analgesic requirements: time to first rescue analgesic, total analgesic consumption within 24 hours.
Pain intensity (VAS at rest and on coughing at 1, 6, 12, and 24 hours).
Adverse events (nausea, vomiting, hypotension, bradycardia, block-related complications).
Patient satisfaction scores as documented in follow-up notes.
1.4. Sample Size
As this was a retrospective study, no prior sample size calculation was performed. All patients who met the inclusion criteria during the study period were included in the analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Group - Erector Spinae Plane Block | – | Procedure: Erector Spinae Plane Block (ESP)Patients receiving ultrasound-guided Erector Spinae Plane (ESP) block immediately after cesarean section under spinal anesthesia. The block is performed at T9 level using 20 mL of 0.25% bupivacaine. Standard perioperative care and analgesia protocols are applied to all participants. Postoperative recovery quality, pain scores, opioid consumption, and adverse events are recorded. |
| RLB Group - Retrolaminar Block | – | Procedure: Retrolaminar Block (RLB)Patients receiving ultrasound-guided Retrolaminar Block (RLB) immediately after cesarean section under spinal anesthesia. The block is performed at T9 level using 20 mL of 0.25% bupivacaine. Standard perioperative care and analgesia protocols are applied. Postoperative recovery quality, pain scores, opioid consumption, and adverse events are recorded. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study includes adult women undergoing elective cesarean section at Elazığ Fethi Sekin City Hospital. Participants will receive either an Erector Spinae Plane (ESP) block or a Retrolaminar Block (RLB) for postoperative analgesia and will be followed for postoperative recovery quality and pain outcomes.
Key inclusion criteria (15 listed)
- Women aged 18-45 years, scheduled for elective cesarean delivery under spinal anesthesia.
- Gestational age ≥37 weeks, singleton pregnancy.
- Undergoing either ESP or RLB for postoperative analgesia.
- ASA Physical Status II-III.
- Ability to understand and complete ObsQoR-11T questionnaire.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Erector Spinae Plane Block (ESP)Ultrasound-guided ESP block performed immediately after cesarean section at T9 level using 20 mL of 0.25% bupivacaine. Standard perioperative care and analgesia protocols are applied. | Procedure or surgery | ESP Group - Erector Spinae Plane Block |
| Retrolaminar Block (RLB)Ultrasound-guided Retrolaminar Block performed immediately after cesarean section at T9 level using 20 mL of 0.25% bupivacaine. Standard perioperative care and analgesia protocols are applied. | Procedure or surgery | RLB Group - Retrolaminar Block |
Primary outcome
Postoperative Recovery Quality After Cesarean Section (ObsQoR-11T)
Time frame: 24 hours postoperatively
The primary outcome is the quality of postoperative recovery, assessed using the Turkish version of the Obstetric Quality-of-Recovery Score (ObsQoR-11T). This validated questionnaire evaluates multidimensional aspects of recovery, including patient comfort, physical and emotional well-being, and functional status. Scores are recorded 24 hours after cesarean section to compare recovery between ESP and RLB groups.
2 secondary outcomes
Postoperative Pain Intensity (Visual Analog Scale)
Time frame: 1, 6, 12, and 24 hours postoperatively
Total Analgesic Consumption
Time frame: 0-24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Postoperative Pain Management, run by Elazıg Fethi Sekin Sehir Hastanesi 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 15 inclusion and 0 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: opening soon, as of the sponsor's last update on 30 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serpil Bayındır (+905055493582, serpilbayindir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Recovery Quality After Cesarean Section (ObsQoR-11T) (time frame: 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 30 Sep 2025.