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NCT Number: NCT07790471

Enhanced Recovery Protocol Compliance and Quality of Recovery After Cesarean Delivery

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.

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Key information

Conditions

Cesarean Section Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Postoperative Recovery Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

Location status: Recruiting

Location contact

emre ulusoy, MD

CONTACT

[email protected]

05379492799

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of Enhanced Recovery Protocol Compliance

Other

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.

Primary outcomes

  1. Obstetric Quality of Recovery-10 Score

    Time frame: 24 hours after cesarean delivery

    Postoperative 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 outcomes

  1. Enhanced Recovery Protocol Compliance

    Time frame: From the preoperative assessment to 24 hours after cesarean delivery

    Overall compliance with enhanced recovery protocol components will be calculated as the percentage of completed preoperative, intraoperative, and postoperative components.

  2. Postoperative Pain Intensity

    Time frame: In the recovery unit and at 2, 6, 12, and 24 hours after cesarean delivery

    Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10, with higher scores indicating greater pain intensity.

  3. Rescue Opioid Requirement

    Time frame: During the first 24 hours after cesarean delivery

    The number of participants requiring rescue opioid medication after cesarean delivery will be recorded.

  4. Total Amsterdam Preoperative Anxiety and Information Scale Score

    Time frame: Before cesarean delivery

    The 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.

  5. Length of Hospital Stay

    Time frame: From cesarean delivery until hospital discharge, assessed up to 7 days

    Duration of hospital stay from the completion of cesarean delivery until formal hospital discharge, measured in hours.

  6. Preoperative Information Requirement

    Time frame: Before cesarean delivery

    Preoperative 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.

  7. Preoperative Anxiety

    Time frame: Before cesarean delivery

    Preoperative 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.

Study contacts

Contact information is provided by the study sponsor or research team.

emre ulusoy, MD

CONTACT

[email protected]

05379492799

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Collaborators

  • Ulusoy, Emre, M.D.

Registry information

Official study title

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

Acronym: ERAC-QoR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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