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

November 25, 2024 updated by: Maram Ashraf Zahr Eldeen, Assiut University

Ultrasongraphy Guided Spinal Anesthesia Versus Landmark 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Landmark Group
patients will receive spinal anesthesia using the surface landmark-guided
Procedure: spinal anesthesia
spinal anesthesia after us-assisted technique
Procedure: spinal anesthesia
spinal anesthesia using the surface landmark-guided
Experimental: Ultrasonography Group
patients will receive spinal anesthesia after us-assisted technique
Procedure: spinal anesthesia
spinal anesthesia after us-assisted technique
Procedure: spinal anesthesia
spinal anesthesia using the surface landmark-guided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • landmark VS US guided

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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