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NCT Number: NCT06707571

Landmark Versus Ultrasongraphy Guided Spinal Anesthesia in Lower Abdominal Surgeries in Cancer Patients: a Randomized Controlled Trial

Spinal anesthesia is a commonly employed technique for lower abdominal surgeries, providing effective anesthesia and analgesia with minimal systemic effects. In cancer patients undergoing such procedures, careful consideration of anesthetic techniques is crucial, given their often-compromised physiological state and the need to minimize postoperative complications. Two approaches to administering spinal anesthesia are Ultrasound (US)-guided and the traditional landmark-based technique.

the aim of the study :To evaluate the efficacy, safety and feasibility of US-guided spinal anesthesia versus the landmark-based technique in cancer patients undergoing lower abdominal surgery.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The traditional landmark method relies on palpating anatomical structures, such as the iliac crests and spinal processes, to guide needle insertion. Although widely used, it can be challenging in patients with anatomical variations, obesity, or previous surgeries, potentially leading to multiple attempts, increased patient discomfort, or complications. On the other hand, Ultrasound (US) imaging has become an increasingly popular tool among anesthesiologists to guide neuraxial blockade. US-guided spinal anesthesia provides real-time visualization of the relevant anatomy, including the spinal canal, ligaments, and surrounding tissues, enabling more accurate needle placement. This technique has gained attention for its potential to improve success rates, reduce complications, and enhance patient comfort, particularly in complex cases such as cancer patients, where precision is vital.

By examining factors such as procedural success rates, patient comfort, complication rates, and overall outcomes, we can better understand the role of ultrasound guidance in optimizing anesthetic care for this vulnerable patient population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 years old
  • Both sex
  • patients with a body mass index (BMI) of 18-40 kg/m2
  • American Society of Anesthesiologists (ASA) physical status classification of I to III.

Exclusion criteria

  • • Patients have a contraindication for regional anesthesia, e.g. coagulopathy.
  • Failed or unsatisfactory intrathecal block.
  • Patients with known hypersensitivity to amide local anesthetics.
  • Local injection site infection or spinal deformity.
  • Severe hypotension.
  • Space occupying lesions of the brain.
  • Hypovolemia.
  • Pregnancy.

Treatment and study plan

Spinal anesthesia

Procedure

spinal anesthesia after us-assisted technique

Primary outcomes

  1. the first-pass success rate of Combined spinal-epidural anesthesia

    Time frame: baseline

    first-pass success was defined as the needle reaching the subarachnoid space within a single insertion attempt, without redirection

Study contacts

Contact information is provided by the study sponsor or research team.

Maram Ashraf Zahr Eldeen, resident doctor

CONTACT

[email protected]

+201222201740

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Ultrasongraphy Guided Spinal Anesthesia Versus Landmark in Lower Abdominal Surgeries in Cancer Patients: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

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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