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Completed

NCT Number: NCT05342922

The Ultrasound Guided Versus Land-mark Location Method for Performing Spinal Anesthesia in Obese Parturients

This study will be investigated whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the lateral position in morbidly obese pregnant women with BMI ≥ 40 who will undergo elective cesarean section.

The primary objective in this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in grade 3 morbidly obese pregnant women according to the Who classification, whose topographic anatomy is difficult.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may have difficulties in determining the poorly palpable surface landmarks in morbidly obese pregnant women.

Manual palpation technique, which is preferred in neuraxial anesthesia, may be difficult in obese pregnant women due to the difficulty in identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease number of attempts in obese parturients.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective cesarean will be screened for enrollment in the study. Patient, the anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups.Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 150 ultrasound-guided neuraxial blocks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Parturient who will receive selective cesarean delivery under spinal anesthesia
  • ASA 2-3 scheduled for elective sections
  • BMI≥40 kg/m2
  • normal singleton pregnancy
  • ≥37 weeks of gestation

Exclusion criteria

  • Multiple gestations
  • Emergency C-section
  • exist contraindications of spinal anesthesia
  • Local anesthetics allergy
  • BMI<40 kg/m2
  • history of lumbar spinal diseases and lumbar surgery
  • Parturient refusal

Treatment and study plan

Ultrasound group

Procedure

In the operating room, all of the patients will receive standard monitoring. Scans will be made in logiditunal parasagittal and transverse midline views with ultrasound. Needle entry sites in the L2-L3 and L3-L4 intervals will be determined as the intersection of the longiditunal and transverse lines.

When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.

Landmark group

Procedure

In the Landmark group, the injection site will be determined using the traditional method of palpating the posterior superior iliac spine.When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.

Primary outcomes

  1. The success rate of first puncture

    Time frame: 30 minute

    Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.

Secondary outcomes

  1. Number of skin punctures

    Time frame: 30 minute

    Skin puncture is defined as any separate skin puncture attempt.

  2. Number of needle pass

    Time frame: 30 minute

    Needle pass is defined as skin puncture plus number of redirection attempts

  3. The procedure duration time

    Time frame: 30 minute

    The duration from initiation of location marking by palpation or ultrasound to obtaining free cerebrospinal fluid flow

  4. Time interval to determine needle insertion site

    Time frame: 30 minute

    Time interval between the operator touches the parturient and the completion of the needle insertion point marking

  5. Time taken for spinal injection

    Time frame: 30 minute

    The time interval between the needle insertion to visualization of cerebrospinal spinal fluid in the spinal needle.

  6. Number of puncture levels

    Time frame: 30 minute

    Move to a second lumbar space after 3 needle insertion attempts

  7. Patient satisfaction The procedure duration

    Time frame: 30 minute

    Patients rated their satisfaction as very satisfied, satisfied, or dissatisfied immediately after the procedure.

  8. incidence of complications during puncture

    Time frame: 30 minute

    Incidence of radicular pain, paresthesia, and blood during spinal needle injection

  9. incidence of postoperative headache

    Time frame: 72 hour

    12-72 hours following spinal anesthesia due to CSF leakage

  10. Incidence of hypotension

    Time frame: 2 hour

    A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg

  11. Failure rate of spinal anesthesia

    Time frame: 120 minute

    Number of parturients who need additional analgesic drug or conversion to general anesthesia

  12. dermatome level of sensory block [ Time Frame: 10 minutes after spinal anesthetic injection ]

    Time frame: 20 minute

    thoracic dermatome level of sensory block assessed by pinprick test

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

Comparison of Ultrasound and Anatomical Land-mark Method in Spinal Anesthesia for Elective Cesarean Section in Obese Parturients With BMI ≥ 40 kg/m2. A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
Jan 25, 2023

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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