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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07440667
Enrollment
160
Registered
2026-02-27
Start date
2026-03-04
Completion date
2027-01-30
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

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

OTHERRestrictive 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.

OTHERLiberal 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.

Sponsors

Nigde Omer Halisdemir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative nausea and vomiting (PONV)0-24 hours postoperativelyOccurrence of nausea and/or vomiting within the first 24 hours after surgery, recorded as present or absent.

Secondary

MeasureTime frameDescription
Incidence and severity of postdural puncture headache (PDPH)24-72 hours postoperativelyOccurrence of postdural puncture headache (PDPH) within 72 hours postoperatively. Severity will be assessed using a standardized pain scale (e.g., numerical rating scale).
Time to first flatusUp to 72 hours postoperativelyTime (in hours) from the end of surgery to the first reported passage of flatus.
Frequency of intraoperative hypotensionIntraoperative periodNumber of hypotensive episodes defined as systolic blood pressure \<90 mmHg or a decrease \>20% from baseline.
Total intraoperative vasopressor doseIntraoperative periodCumulative dose of ephedrine administered during surgery.

Countries

Turkey (Türkiye)

Contacts

CONTACTPınar Erdoğan, Assoc. Prof.
pinar.erdogan@ohu.edu.tr+905233646954
CONTACTSeval Kılbasanlı, MD
pinar.erdogan@ohu.edu.tr+905057246364
PRINCIPAL_INVESTIGATORPınar Erdoğan, Assoc Prof

Niğde Ömer Halisdemir University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026