Restrictive vs Liberal Intraoperative Fluid Strategy and Postoperative Outcomes After Elective Cesarean Section

NCT07440667 | Recruiting

• 1 other identifier: 2025/154
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia for elective cesarean section is frequently associated with hemodynamic instability and postoperative complications such as postoperative nausea and vomiting (PONV) and delayed gastrointestinal recovery. Although intraoperative fluid administration is routinely used to prevent spinal-induced hypotension, the optimal fluid strategy remains unclear. Both restrictive and liberal fluid approaches may influence maternal hemodynamics and postoperative outcomes through different physiological mechanisms. This prospective, single-center, randomized controlled trial aims to compare restrictive (≤3 mL/kg/h) and liberal (\>3 mL/kg/h) intraoperative crystalloid fluid strategies in patients undergoing elective cesarean section under spinal anesthesia. The primary outcome is the incidence of PONV within the first 24 hours postoperatively. Secondary outcomes include postdural puncture headache (PDPH), time to first flatus, hypotension frequency, and vasopressor requirements.

Conditions

Cesarean Section; Postoperative Nausea and Vomiting (PONV); Postdural Puncture Headache (PDPH); Postoperative Ileus; Gastrointestinal Recovery

Keywords

Cesarean Section; Spinal Anesthesia; Intraoperative Fluid Therapy; Restrictive Fluid Strategy; Liberal Fluid Strategy; Postoperative Nausea and Vomiting; Postdural Puncture Headache; Gastrointestinal Recovery; Hypotension; Vasopressor Use

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting (PONV)

  Occurrence of nausea and/or vomiting within the first 24 hours after surgery, recorded as present or absent.

  0-24 hours postoperatively

Secondary Outcomes (4)

• Incidence and severity of postdural puncture headache (PDPH)

  24-72 hours postoperatively

• Time to first flatus

  Up to 72 hours postoperatively

• Frequency of intraoperative hypotension

  Intraoperative period

• Total intraoperative vasopressor dose

  Intraoperative period

Study Arms (2)

Restrictive intraoperative fluid strategy (≤3 mL/kg/h)

EXPERIMENTAL

Participants undergoing elective cesarean section under spinal anesthesia will receive intraoperative crystalloid at a target average infusion rate of ≤3 mL/kg/h. Standardized spinal anesthesia technique and intraoperative management will be applied. Hypotension will be treated according to the predefined rescue protocol (e.g., ephedrine and/or additional fluid bolus as clinically indicated).

Other: Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h)

Liberal intraoperative fluid strategy (>3 mL/kg/h)

ACTIVE COMPARATOR

Participants undergoing elective cesarean section under spinal anesthesia will receive intraoperative crystalloid at a target average infusion rate of \>3 mL/kg/h. Standardized spinal anesthesia technique and intraoperative management will be applied. Hypotension will be treated according to the predefined rescue protocol (e.g., ephedrine and/or additional fluid bolus as clinically indicated).

Other: Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h)

Interventions

Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h) OTHER

Intraoperative crystalloid administration targeting an average rate of ≤3 mL/kg/h during elective cesarean section under spinal anesthesia.

Restrictive intraoperative fluid strategy (≤3 mL/kg/h)

Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h) OTHER

Intraoperative crystalloid administration targeting an average rate of \>3 mL/kg/h during elective cesarean section under spinal anesthesia.

Liberal intraoperative fluid strategy (>3 mL/kg/h)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 18-45 years
• ASA physical status II
• Scheduled for elective cesarean section under spinal anesthesia
• Provision of written informed consent

You may not qualify if:

• Emergency cesarean section
• Preeclampsia or eclampsia
• Known cardiac failure
• Known renal failure
• Known hepatic failure
• Coagulopathy
• Contraindication to spinal anesthesia
• Conversion to general anesthesia
• Major technical complications during spinal anesthesia
• Refusal to participate

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University Hospital

Niğde, Merkez, 51240, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Post-Dural Puncture Headache; Hypotension

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pınar Erdoğan, Assoc Prof

  Niğde Ömer Halisdemir University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pınar Erdoğan, Assoc. Prof.

CONTACT

+905233646954; pinar.erdogan@ohu.edu.tr

Seval Kılbasanlı, MD

CONTACT

+905057246364; pinar.erdogan@ohu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to group allocation. The anesthesia team will not be blinded due to the nature of the intervention (intraoperative fluid strategy). Postoperative outcomes will be collected by a blinded assessor who is not involved in intraoperative care and has no access to allocation information. Group allocation will be recorded in a separate study log and concealed from participants and outcome assessors until completion of follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants are randomized in a 1:1 ratio to one of two parallel groups receiving either a restrictive (≤3 mL/kg/h) or a liberal (\>3 mL/kg/h) intraoperative crystalloid fluid strategy during elective cesarean section under spinal anesthesia. Each participant is assigned to a single intervention arm and followed for postoperative outcomes.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)