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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).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Serpil Bayındır contact

+905055493582

serpilbayindir@gmail.com

Turkey (Türkiye)1 site
  • Elazığ Fethi Sekin City Hospital

    Elâzığ, Seçiniz, 23100

    Serpil Bayındır, 05055493582, serpilbayindir@gmail.com.tr

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07181902
Study groupRoleWhat they receive
ESP Group - Erector Spinae Plane BlockPatients 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 BlockPatients 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted18 Sep 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion15 Dec 2025 (estimated)

Resources

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)
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

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.

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