Skip to content

Enhanced Recovery Protocol Compliance and Quality of Recovery After Cesarean Delivery

Effect of Enhanced Recovery After Cesarean Delivery Protocol Compliance on Postoperative Quality of Recovery in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: A Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07790471
Acronym
ERAC-QoR
Enrollment
150
Registered
2026-08-27
Start date
2026-08-15
Completion date
2026-10-15
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Postoperative Pain, Postoperative Recovery

Keywords

Enhanced Recovery After Cesarean Delivery, ERAC, Obstetric Quality of Recovery, ObsQoR-10, Spinal Anesthesia, Maternal Recovery, Preoperative Anxiety

Brief summary

This prospective observational study will evaluate whether adherence to enhanced recovery after cesarean delivery protocols is associated with postoperative recovery quality in women undergoing elective cesarean delivery under spinal anesthesia. A total of 150 participants will be enrolled. Recovery quality will be assessed using the Turkish version of the Obstetric Quality of Recovery-10 questionnaire at 24 hours after surgery. Pain, opioid use, nausea, mobilization, oral intake, breastfeeding, and patient satisfaction will also be evaluated.

Interventions

OTHERAssessment of Enhanced Recovery Protocol Compliance

Adherence to routinely implemented enhanced recovery after cesarean delivery components will be assessed during the preoperative, intraoperative, and postoperative periods. Each completed component will receive one point, and overall adherence will be calculated as a percentage. No additional interventions will be administered.

Sponsors

Bursa City Hospital
Lead SponsorOTHER_GOV
Ulusoy, Emre, M.D.
CollaboratorINDIV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older * Scheduled for elective cesarean delivery * Planned spinal anesthesia * American Society of Anesthesiologists physical status II or III * Ability to read and understand Turkish * Provision of written informed consent

Exclusion criteria

* Emergency cesarean delivery * General anesthesia or conversion from spinal to general anesthesia * Major obstetric hemorrhage * Requirement for postoperative intensive care * Chronic opioid use * Chronic pain syndrome * Severe psychiatric disease * Severe neurological disease * Inability to communicate * Cognitive impairment preventing completion of study questionnaires * Refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Obstetric Quality of Recovery-10 Score24 hours after cesarean deliveryPostoperative recovery quality will be assessed using the Turkish version of the Obstetric Quality of Recovery-10 questionnaire. Total scores range from 0 to 100, with higher scores indicating better recovery.

Secondary

MeasureTime frameDescription
Enhanced Recovery Protocol ComplianceFrom the preoperative assessment to 24 hours after cesarean deliveryOverall compliance with enhanced recovery protocol components will be calculated as the percentage of completed preoperative, intraoperative, and postoperative components.
Postoperative Pain IntensityIn the recovery unit and at 2, 6, 12, and 24 hours after cesarean deliveryPain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10, with higher scores indicating greater pain intensity.
Rescue Opioid RequirementDuring the first 24 hours after cesarean deliveryThe number of participants requiring rescue opioid medication after cesarean delivery will be recorded.
Total Amsterdam Preoperative Anxiety and Information Scale ScoreBefore cesarean deliveryThe overall Amsterdam Preoperative Anxiety and Information Scale score will be calculated. Scores range from 6 to 30, with higher scores indicating greater anxiety and information needs.
Length of Hospital StayFrom cesarean delivery until hospital discharge, assessed up to 7 daysDuration of hospital stay from the completion of cesarean delivery until formal hospital discharge, measured in hours.
Preoperative Information RequirementBefore cesarean deliveryPreoperative information needs will be evaluated using the information subscale of the Amsterdam Preoperative Anxiety and Information Scale. Scores range from 2 to 10, with higher scores indicating greater information needs.
Preoperative AnxietyBefore cesarean deliveryPreoperative anxiety will be evaluated using the anxiety subscale of the Amsterdam Preoperative Anxiety and Information Scale. Scores range from 4 to 20, with higher scores indicating greater anxiety.

Countries

Turkey (Türkiye)

Contacts

CONTACTemre ulusoy, MD
emreulusoy36@gmail.com05379492799

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026