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Completed

NCT Number: NCT03792191

Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery

The study will compare between preprocedural ultrasonography and the conventional palpation technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery

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Key information

Conditions

Anesthesia, Spinal Cesarean Section Spinal Ultrasound

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

This randomized, controlled, double-blind study will be conducted on ASA physical status II-III obese parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. The study subjects will be assigned to 2 equal groups. In the ultrasonography group, lumbar spinal ultrasonography will be performed before administration of spinal anesthesia. In the palpation group, conventional palpation of the anatomical landmarks will be performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar Spinal Ultrasonography

Radiation

Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the intervertebral space with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.

Sham Ultrasound Procedure

Radiation

Moving the ultrasound probe on the patient's back with the machine in the freeze position.

Conventional Landmark Palpation

Procedure

Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) is assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest intervertebral space. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.

Spinal anesthesia

Procedure

Spinal anesthesia using a 25- or 22-gauge spinal needle

Intrathecal Bupivacaine

Drug

Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space

Intrathecal Fentanyl

Drug

Fentanyl 15 μg will be administered in the subarachnoid space

Primary outcomes

  1. Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow

    Time frame: 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 outcomes

  1. Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow

    Time frame: 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.

  2. Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass

    Time frame: 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.

  3. Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture

    Time frame: 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.

  4. Duration of the Spinal Procedure

    Time frame: 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

  5. Patient Satisfaction

    Time frame: 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).

  6. Number of Participants With Vascular Puncture

    Time frame: 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

  7. Number of Participants With Paresthesia

    Time frame: 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

  8. Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow

    Time frame: 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.

  9. Number of Participants With Failed Spinal Block

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 3, 2019
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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