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

NCT03792191 | Completed Results

• 1 other identifier: MD.18.02.29
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia, Spinal; Cesarean Section; Spinal Ultrasound

Outcome Measures

Primary Outcomes (1)

• Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow

  Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.

  Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes

Secondary Outcomes (9)

• 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

• 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

• 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

• Duration of the Spinal Procedure

  Assessed from enrollment in the study until completion of cesarean delivery

• Patient Satisfaction

  Assessed at 1 minute after intrathecal injection

Study Arms (2)

Ultrasonography

EXPERIMENTAL

Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.

Radiation: Lumbar Spinal Ultrasonography; Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl

Palpation

ACTIVE COMPARATOR

Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.

Radiation: Sham Ultrasound Procedure; Procedure: Conventional Landmark Palpation; Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl

Interventions

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.

Ultrasonography

Sham Ultrasound Procedure RADIATION

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

Palpation

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.

Palpation

Spinal Anesthesia PROCEDURE

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

Palpation; Ultrasonography

Intrathecal Bupivacaine DRUG

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

Palpation; Ultrasonography

Intrathecal Fentanyl DRUG

Fentanyl 15 μg will be administered in the subarachnoid space

Palpation; Ultrasonography

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status II-III parturients
• Full term singleton pregnancy
• Body mass index ≥ 35 Kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (1)

• Tawfik MM, Tolba MA, Ismail OM, Messeha MM. Ultrasonography versus palpation for spinal anesthesia in obese parturients undergoing cesarean delivery: a randomized controlled trial. Reg Anesth Pain Med. 2024 Jan 11;49(1):41-48. doi: 10.1136/rapm-2022-104272.

  PMID: 37188389 DERIVED

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Mohamed Mohamed Tawfik
• Organization: Mansoura University

m2tawfik@mans.edu.eg

1001183400

Study Officials

• Mohamed M Tawfik, MD

  Mansoura University Hospital

  STUDY DIRECTOR

• Mohamed A Tolba, MSc

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of anesthesia and surgical intensive care, Primary investigator

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 3, 2019
• Study Start: January 16, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: May 24, 2021
• Results First Posted: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)