Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-09 @ 6:27 AM
Study NCT ID:
NCT07181902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
Elazıg Fethi Sekin Sehir Hastanesi
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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). 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: