Enhanced Recovery Protocol Compliance and Quality of Recovery After Cesarean Delivery

NCT07790471 | Recruiting

• 1 other identifier: BSHE6
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Postoperative Recovery; Postoperative Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Obstetric Quality of Recovery-10 Score

  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.

  24 hours after cesarean delivery

Secondary Outcomes (7)

• Enhanced Recovery Protocol Compliance

  From the preoperative assessment to 24 hours after cesarean delivery

• Postoperative Pain Intensity

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

• Rescue Opioid Requirement

  During the first 24 hours after cesarean delivery

• Total Amsterdam Preoperative Anxiety and Information Scale Score

  Before cesarean delivery

• Length of Hospital Stay

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

Study Arms (3)

High ERAC Compliance

Women undergoing elective cesarean delivery under spinal anesthesia with adherence to 80% or more of enhanced recovery protocol components.

Other: Assessment of Enhanced Recovery Protocol Compliance

Moderate ERAC Compliance

Women undergoing elective cesarean delivery under spinal anesthesia with adherence to 60% to 79% of enhanced recovery protocol components.

Other: Assessment of Enhanced Recovery Protocol Compliance

Low ERAC Compliance

Women undergoing elective cesarean delivery under spinal anesthesia with adherence to less than 60% of enhanced recovery protocol components.

Other: Assessment of Enhanced Recovery Protocol Compliance

Interventions

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.

High ERAC Compliance; Low ERAC Compliance; Moderate ERAC Compliance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult pregnant women aged 18 years or older undergoing elective cesarean delivery under spinal anesthesia at Bursa City Hospital, Türkiye. Eligible participants will have American Society of Anesthesiologists physical status II or III and will be enrolled consecutively during the study period.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa City Hospital: lead
• Ulusoy, Emre, M.D.: collaborator

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

emre ulusoy, MD

CONTACT

05379492799; emreulusoy36@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Reanimation, M.D.

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 27, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)