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Clinical Trials/NCT06707571
NCT06707571Not yet recruitingNot Applicable

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

Assiut University0 sites52 target enrollmentStarted: December 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
52
Primary Endpoint
the first-pass success rate of Combined spinal-epidural anesthesia

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Patients will be randomly assigned to receive spinal anesthesia using the surface landmark-guided (landmark group) or preprocedural ultrasound-assisted (ultrasound group) technique using a computer-generated table of random numbers. Group allocation will be concealed by sequentially numbered, sealed opaque envelopes, which are opened only by the attending anesthesiologist immediately before the procedure.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age >18 years old
  • •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.

Arms & Interventions

Landmark Group

Experimental

patients will receive spinal anesthesia using the surface landmark-guided

Intervention: spinal anesthesia (Procedure)

Ultrasonography Group

Experimental

patients will receive spinal anesthesia after us-assisted technique

Intervention: spinal anesthesia (Procedure)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maram Ashraf Zahr Eldeen

Anesthesia, Intensive Care and Pain Management Department South Egypt cancer Institute

Assiut University

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