Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cesarean Sections

NCT07104890 | Completed

• 1 other identifier: GOEAH-ERAS-CS01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of the Enhanced Recovery After Surgery (ERAS) protocol on early postoperative recovery in women undergoing elective cesarean section. Eighty-four pregnant women, aged 18 years or older, at 37 weeks of gestation or beyond, without chronic medical conditions, and classified as ASA I-II, were enrolled. Participants were randomly assigned to either: ERAS group - received the ERAS protocol, including early oral intake, early mobilization, multimodal analgesia, and enhanced perioperative care Control group - received standard perioperative cesarean section care The study compared breastfeeding initiation time, gas passage, oral intake, mobilization time, and postoperative pain scores (VAS) between the two groups. The aim is to determine whether ERAS can accelerate recovery, reduce pain, and improve maternal comfort after elective cesarean delivery.

Conditions

Elective Cesarean Section; Postoperative Recovery; Enhanced Recovery After Surgery (ERAS)

Keywords

Cesarean Section; Elective Cesarean; Enhanced Recovery After Surgery; ERAS; Postoperative Recovery; Early Mobilization; Postoperative Pain; Multimodal Analgesia; Obstetric Surgery

Outcome Measures

Primary Outcomes (1)

• Time to First Mobilization After Cesarean Section

  Time from the end of elective cesarean section surgery to the patient's first ambulation, measured in hours. Early mobilization reflects enhanced postoperative recovery and is a key indicator of the ERAS protocol's effectiveness.

  Within 24 hours postoperatively

Secondary Outcomes (1)

• Incidence of Postoperative Nausea and Vomiting

  Within 48 hours postoperatively

Study Arms (2)

ERAS Protocol Group

EXPERIMENTAL

Participants in this arm will receive the Enhanced Recovery After Surgery (ERAS) protocol during elective cesarean section. The ERAS protocol includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, and gum chewing to stimulate bowel function. Postoperative outcomes such as breastfeeding initiation, gas passage, oral intake time, mobilization, and VAS pain scores will be evaluated.

Behavioral: Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an

Standard Care Group

ACTIVE COMPARATOR

Participants in this arm will receive standard perioperative cesarean care, which includes overnight fasting, delayed oral intake until gas passage, routine analgesia with paracetamol, NSAIDs and opioids as needed, later urinary catheter removal, and routine postoperative mobilization. Outcomes will be assessed similarly to the ERAS group.

Behavioral: Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an

Interventions

Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an BEHAVIORAL

The Enhanced Recovery After Surgery (ERAS) Protocol for elective cesarean section includes a multimodal perioperative care approach aimed at accelerating postoperative recovery. Key components are early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early removal of the urinary catheter, and gum chewing to stimulate bowel function. This protocol is compared with Standard Perioperative Cesarean Care, which involves overnight fasting, delayed oral intake until bowel function returns, conventional analgesia, later mobilization, and routine catheter removal.

ERAS Protocol Group; Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only biologically female participants who are pregnant and scheduled for elective cesarean section are eligible for the study. Self-identified gender does not alter eligibility; participants must be biologically female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women aged 18 years or older
• Gestational age ≥37 weeks
• Classified as ASA I or ASA II
• Scheduled for elective cesarean section under spinal anesthesia
• Able and willing to provide informed consent
• No chronic systemic diseases

You may not qualify if:

• Age \<18 years
• Gestational age \<37 weeks
• Emergency cesarean delivery
• ASA III or higher
• Presence of obstetric complications (e.g., preeclampsia, placenta previa, placental abruption, fetal distress)
• Chronic comorbidities (e.g., diabetes, hypertension, cardiac or pulmonary disease)
• Declines spinal anesthesia or unable to provide consent

Sponsors & Collaborators

• Havva Betül Bacak: lead

Study Sites (1)

Bartın City Hospital

Bartın, Turkey (Türkiye)

Location

Related Publications (2)

• Khalafallah AM, Susic N, Shah KH, Knott MV, Berke CN, Gurses ME, Lu VM, Ivan ME, Komotar RJ, Shah AH. Evaluating safety and feasibility of same-day discharge after laser interstitial thermal therapy: a pilot study with a matched control group. J Neurooncol. 2025 Sep;174(2):341-347. doi: 10.1007/s11060-025-05055-4. Epub 2025 May 12.

  PMID: 40355785 BACKGROUND

• Zhang X, Ruan Y, Yuan Y, Li K. Is it necessary to maintain high adherence to enhanced recovery after surgery (ERAS) protocols?-A systematic review and meta-analysis. Curr Probl Surg. 2025 Aug;69:101814. doi: 10.1016/j.cpsurg.2025.101814. Epub 2025 May 30. No abstract available.

  PMID: 40716849 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Enhanced Recovery After Surgery; Clinical Protocols; Early Ambulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D

Model Details: This is a single-center, prospective, randomized, parallel-group clinical trial. Participants were randomly assigned in a 1:1 ratio to either the ERAS protocol group or the standard care control group. Both groups were followed concurrently for postoperative recovery outcomes after elective cesarean section.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: October 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)