N/A
N=280
Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery
Anesthesia, Spinal · Cesarean Section · Spinal Ultrasound
Bottom Line
View on ClinicalTrials.gov: NCT03792191 ↗Enrolled (actual)
280
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow — 3; 3 needle passes — p=0.62
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lumbar Spinal Ultrasonography (Radiation); Sham Ultrasound Procedure (Radiation); Conventional Landmark Palpation (Procedure); Spinal Anesthesia (Procedure); Intrathecal Bupivacaine (Drug); Intrathecal Fentanyl (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- Mansoura University
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow |
3; 3 | 0.62 |
| SECONDARY Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow |
1; 1 | 0.58 |
| SECONDARY Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass |
40; 45 | 0.6 |
| SECONDARY Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture |
108; 111 | 0.77 |
| SECONDARY Duration of the Spinal Procedure |
76; 59 | 0.077 |
| SECONDARY Patient Satisfaction |
5; 4 | 0.1 |
| SECONDARY Number of Participants With Vascular Puncture |
9; 9 | >0.99 |
| SECONDARY Number of Participants With Paresthesia |
16; 17 | >0.99 |
| SECONDARY Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow |
0; 0 | — |
| SECONDARY Number of Participants With Failed Spinal Block |
3; 4 | >0.99 |
Summary
The study will compare between preprocedural ultrasonography and the conventional palpation technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists physical status II-III parturients
- Full term singleton pregnancy
- Body mass index ≥ 35 Kg/m2
Exclusion Criteria
- Age < 19 years
- Women presenting in labor
- Contraindications to neuraxial anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection)
- Significant spinal deformities or previous spinal surgery
- Preeclampsia
Data sourced from ClinicalTrials.gov (NCT03792191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.