NCT07181902

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 12, 2025

Last Update Submit

September 24, 2025

Conditions

Keywords

Cesarean SectionRetrolaminar BlockObsQoR-11TErector Spinae Plane Block

Outcome Measures

Primary Outcomes (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.

    24 hours postoperatively

Secondary Outcomes (2)

  • Postoperative Pain Intensity (Visual Analog Scale)

    1, 6, 12, and 24 hours postoperatively

  • Total Analgesic Consumption

    0-24 hours postoperatively

Study Arms (2)

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.

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.

Procedure: Retrolaminar Block (RLB)

Interventions

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.

ESP Group - Erector Spinae Plane Block

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.

RLB Group - Retrolaminar Block

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Seçiniz, 23100, Turkey (Türkiye)

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physician

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 18, 2025

Study Start

October 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 15, 2025

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations