- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07406373
Intra-abdominal Pressure, Abdominal Circumference, and Spinal Block Level in Cesarean Section
The Effect of Intra-abdominal Pressure and Abdominal Circumference on Sensory Block Level After Spinal Anesthesia in Pregnant Women Undergoing Cesarean Section
Spinal anesthesia is commonly used for cesarean section and provides effective anesthesia with rapid onset. However, the spread of spinal anesthesia may vary among pregnant women due to physiological and anatomical changes during pregnancy. Increased intra-abdominal pressure and abdominal circumference may influence cerebrospinal fluid dynamics and affect the level of sensory block achieved after spinal anesthesia.
This prospective observational study aims to evaluate the relationship between intra-abdominal pressure, abdominal circumference, and the maximum sensory block level following spinal anesthesia in pregnant women undergoing cesarean section. Intra-abdominal pressure and abdominal circumference will be measured before surgery, and sensory block levels and hemodynamic parameters will be assessed after spinal anesthesia. The findings of this study may help to better understand factors affecting spinal block spread in pregnant patients.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kütahya
-
Kütahya, Kütahya, Turkey (Türkiye)
- Kütahya Şehir Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women aged 18-40 years
- Scheduled for elective cesarean section at Kütahya City Hospital
- Planned spinal anesthesia
- ASA physical status II-III
- Provided written informed consent
Exclusion Criteria:
- Refusal to participate in the study
- Emergency cesarean section
- Preeclampsia or other hypertensive disorders of pregnancy
- Onset of labor or premature rupture of membranes
- Clinical conditions affecting intra-abdominal pressure, including peripheral edema or ascites
- Height <140 cm or >180 cm
- Body mass index < 40 kg/m²
- Spinal deformity or history of spinal surgery
- Contraindications to neuraxial anesthesia
- Known allergy to bupivacaine
- Requirement for additional surgical procedures other than cesarean section
- Conditions contraindicating or interfering with intra-abdominal pressure measurement, including active or previous postdural puncture headache, neurogenic bladder, hematuria, or incidental abdominal mass
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum sensory block level after spinal anesthesia
Time Frame: Within the first 30 minutes after spinal anesthesia
|
The maximum dermatomal level of sensory block assessed by loss of cold sensation after spinal anesthesia.
|
Within the first 30 minutes after spinal anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intra-abdominal pressure
Time Frame: Baseline (preoperative, before spinal anesthesia) and early postoperative period (within 30 minutes after cesarean section)
|
Intra-abdominal pressure measured in the preoperative period before spinal anesthesia and in the postoperative period following cesarean section using an intravesical measurement technique.
|
Baseline (preoperative, before spinal anesthesia) and early postoperative period (within 30 minutes after cesarean section)
|
|
Abdominal circumference
Time Frame: Baseline (preoperative, before spinal anesthesia) and early postoperative period (within 30 minutes after cesarean section)
|
Abdominal circumference measured at the level of the umbilicus before spinal anesthesia and in the postoperative period following cesarean section.
|
Baseline (preoperative, before spinal anesthesia) and early postoperative period (within 30 minutes after cesarean section)
|
|
Incidence of hypotension after spinal anesthesia
Time Frame: Within the first 30 minutes after spinal anesthesia
|
Hypotension defined as mean arterial pressure <65 mmHg measured during the first 30 minutes after spinal anesthesia.
|
Within the first 30 minutes after spinal anesthesia
|
|
Vasopressor requirement
Time Frame: Perioperative period
|
Requirement and total dose of vasopressor agents administered after spinal anesthesia.
|
Perioperative period
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025/08-28
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Kafrelsheikh UniversityNot yet recruitingEctopic PregnancyEgypt
-
Meir Medical CenterRecruiting
-
Bagcilar Training and Research HospitalRecruitingEctopic PregnancyTurkey (Türkiye)
-
MELISA Institute Genomics & Proteomics Research...RecruitingHealthy | Pregnancy | Early Pregnancy | Early Pregnancy Loss | ChildbirthChile
-
Turku University HospitalUniversity of TurkuCompleted
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance