NCT07438171

Brief Summary

The goal of this observational study is to evaluate the impact of four different spinal anesthesia regimens on maternal satisfaction following cesarean delivery. The main questions this study aims to answer are:

  • Primary outcome: Patient satisfaction with the provided analgesia during the first 24 hours postoperatively.
  • Secondary outcome: The need for rescue analgesics. Participants will complete a specially designed questionnaire 24 hours after cesarean delivery.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 22, 2026

Last Update Submit

February 22, 2026

Conditions

ParturientsElective Cesarean Delivery

Keywords

Maternal satisfactionSpinal anesthesiacesarean deliverypostcesarean analgesia

Outcome Measures

Primary Outcomes (1)

  • Maternal satisfaction with provided analgesia during first 24 h following cesarean delivery

    24 hours

Secondary Outcomes (1)

  • The need for rescue analgesics

    24 hours

Interventions

Bupivacaine %0.5 (hyperbaric)DRUG

Only Bupivacaine %0.5 (hyperbaric) for spinal anesthesia

Bupivacaine %0.5 (hyperbaric) and morphineDRUG

Combination of bupivacaine and morphine for spinal anesthesia

Bupivacaine %0.5 (hyperbaric), morphine and fentanyl 15DRUG

Bupivacaine %0.5 (hyperbaric) , morphine and fentanyl 15 mcg for spinal anesthesia

Bupivacaine, morphine and fentanyl 20DRUG

Bupivacaine, morphine and fentanyl 20 mcg for spinal anesthesia

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women, 18- 45 y old, with singleton pregnancy, scheduled for elective cesarean delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

MorphineBupivacaine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02