Restrictive vs Liberal Intraoperative Fluid Strategy and Postoperative Outcomes After Elective Cesarean Section
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h), Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h).
- Who it may be relevant to
- Registry conditions: Cesarean Section, Postoperative Nausea and Vomiting (PONV), Postdural Puncture Headache (PDPH), Postoperative Ileus. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Randomized Controlled Trial Comparing Restrictive and Liberal Intraoperative Fluid Strategies on Postoperative Nausea and Vomiting and Gastrointestinal Recovery After Elective Cesarean Section Under Spinal Anesthesia
Overview
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.
Detailed description
Spinal anesthesia is the preferred anesthetic technique for elective cesarean section; however, it is frequently associated with sympathetic blockade-induced hypotension. Intraoperative crystalloid administration is commonly used to mitigate hemodynamic instability, yet the optimal fluid strategy remains controversial. Liberal fluid administration may reduce the incidence or severity of hypotension but can contribute to tissue edema, including gastrointestinal wall edema, potentially delaying the recovery of bowel function. Conversely, restrictive fluid strategies may limit fluid overload but could increase vasopressor requirements and compromise splanchnic perfusion. The balance between these approaches and their influence on postoperative maternal outcomes has not been clearly established.
Postoperative nausea and vomiting (PONV) remains one of the most common and distressing complications following cesarean section. Hemodynamic fluctuations, vasopressor use, and visceral perfusion changes may all contribute to its development. In addition, delayed gastrointestinal recovery and postdural puncture headache (PDPH) are relevant postoperative outcomes that may be influenced by intraoperative fluid management.
This prospective, single-center, parallel-group randomized controlled trial is designed to compare two intraoperative crystalloid fluid strategies in patients undergoing elective cesarean section under spinal anesthesia. Patients will be randomized in a 1:1 ratio to receive either a restrictive (≤3 mL/kg/h) or a liberal (\>3 mL/kg/h) intraoperative fluid approach. All other anesthetic procedures, spinal technique, and perioperative management will be standardized according to institutional protocol.
The primary outcome of the study is the incidence of PONV within the first 24 postoperative hours. Secondary outcomes include the incidence and severity of PDPH, time to first flatus as a marker of gastrointestinal recovery, frequency of hypotension, and vasopressor requirements. Intraoperative hemodynamic parameters and fluid administration data will be recorded prospectively.
The study aims to clarify whether intraoperative fluid volume influences postoperative maternal recovery and to contribute evidence toward optimizing perioperative fluid management in elective cesarean section.
Interventions
- Other Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h)
Intraoperative crystalloid administration targeting an average rate of ≤3 mL/kg/h during elective cesarean section under spinal anesthesia. - Other Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h)
Intraoperative crystalloid administration targeting an average rate of \>3 mL/kg/h during elective cesarean section under spinal anesthesia.
Primary outcome measures
- Incidence of postoperative nausea and vomiting (PONV) [Time frame: 0-24 hours postoperatively]
Secondary outcome measures (4)
- Incidence and severity of postdural puncture headache (PDPH) [Time frame: 24-72 hours postoperatively]
- Time to first flatus [Time frame: Up to 72 hours postoperatively]
- Frequency of intraoperative hypotension [Time frame: Intraoperative period]
- Total intraoperative vasopressor dose [Time frame: Intraoperative period]
Eligibility criteria
Inclusion criteria
- Female patients aged 18-45 years
- ASA physical status II
- Scheduled for elective cesarean section under spinal anesthesia
- Provision of written informed consent
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Niğde Ömer Halisdemir University Hospital — Niğde
Identifiers
NCT: NCT07440667 · 2025/154