Trial · NCT03792191
Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery
NCT03792191, Not applicable, Completed, Mansoura University; results first posted 2021-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery. Trials, record NCT03792191. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03792191
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery
- NCT number
- NCT03792191
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 280 participants, actual
- Lead sponsor
- Mansoura University
- Conditions
- Anesthesia, Spinal, Cesarean Section, Spinal Ultrasound
- Interventions
- Lumbar Spinal Ultrasonography, Sham Ultrasound Procedure, Conventional Landmark Palpation, Spinal Anesthesia, Intrathecal Bupivacaine, Intrathecal Fentanyl
- First posted
- 2019-01-03
- Last updated
- 2021-05-24
- Results first posted
- 2021-05-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt. |
| Secondary | Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt. |
| Secondary | Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt. |
| Secondary | Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt. |
| Secondary | Duration of the Spinal Procedure | Assessed from enrollment in the study until completion of cesarean delivery | The duration from starting the first skin puncture by the spinal needle to obtaining free CSF flow |
| Secondary | Patient Satisfaction | Assessed at 1 minute after intrathecal injection | Patient satisfaction from the procedure assessed immediately after intrathecal injection using a 5-point scale (1 = very unsatisfied; 2 = unsatisfied; 3 = fair; 4 = satisfied; and 5 = very satisfied). |
| Secondary | Number of Participants With Vascular Puncture | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Number of participants with unintentional vascular puncture by the needle during performing the spinal procedure |
| Secondary | Number of Participants With Paresthesia | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Number of participants with paresthesia reported by the subjects during performing the spinal procedure |
| Secondary | Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Number of participants with failure to obtain free cerebrospinal fluid flow after adequate needle passes at 6 separate skin punctures. |
| Secondary | Number of Participants With Failed Spinal Block | Assessed up to 20 minutes after intrathecal injection | Number of participants with failed spinal block defined as an upper sensory level below T6 assessed by pinprick. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | needle passes | MEDIAN | |
| SECONDARY | Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | skin punctures | MEDIAN | |
| SECONDARY | Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of the Spinal Procedure | Assessed from enrollment in the study until completion of cesarean delivery | seconds | MEDIAN | |
| SECONDARY | Patient Satisfaction | Assessed at 1 minute after intrathecal injection | units on a scale | MEDIAN | |
| SECONDARY | Number of Participants With Vascular Puncture | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Paresthesia | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Failed Spinal Block | Assessed up to 20 minutes after intrathecal injection | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow | Ultrasonography | 3 | Full Range 1 to 34 | needle passes | |
| Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow | Palpation | 3 | Full Range 1 to 23 | needle passes | |
| Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow | Ultrasonography | 1 | Full Range 1 to 6 | skin punctures | |
| Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow | Palpation | 1 | Full Range 1 to 4 | skin punctures | |
| Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass | Ultrasonography | 40 | Participants | ||
| Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass | Palpation | 45 | Participants | ||
| Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture | Ultrasonography | 108 | Participants | ||
| Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture | Palpation | 111 | Participants | ||
| Duration of the Spinal Procedure | Ultrasonography | 76 | Full Range 26 to 734 | seconds | |
| Duration of the Spinal Procedure | Palpation | 59 | Full Range 19 to 700 | seconds |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ultrasonography | 140 | |
| Overall Study | STARTED | Palpation | 140 | |
| Overall Study | COMPLETED | Ultrasonography | 140 | |
| Overall Study | COMPLETED | Palpation | 140 | |
| Overall Study | NOT COMPLETED | Ultrasonography | 0 | |
| Overall Study | NOT COMPLETED | Palpation | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ultrasonography | 0 | 140 |
| Total, all-cause mortality | Palpation | 0 | 140 |
| Total, other adverse events | Ultrasonography | 0 | 140 |
| Total, other adverse events | Palpation | 0 | 140 |
| Total, serious adverse events | Ultrasonography | 0 | 140 |
| Total, serious adverse events | Palpation | 0 | 140 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37188389 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ultrasonography vs Palpation: Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass | Trial comparisons |
| Ultrasonography vs Palpation: Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture | Trial comparisons |
| Ultrasonography vs Palpation: Number of Participants With Vascular Puncture | Trial comparisons |
| Ultrasonography vs Palpation: Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow | Trial comparisons |
| Ultrasonography vs Palpation: Number of Participants With Paresthesia | Trial comparisons |
| Ultrasonography vs Palpation: Number of Participants With Failed Spinal Block | Trial comparisons |
| Ultrasonography vs Palpation: deaths from any cause | Trial comparisons |
| Ultrasonography vs Palpation: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03792191
GET https://conductscience.org/api/trials/v1/NCT03792191/registered