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

NCT ID: NCT06707571

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-01-01

Brief Summary

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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

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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.

Conditions

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Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Landmark Group

patients will receive spinal anesthesia using the surface landmark-guided

Group Type EXPERIMENTAL

spinal anesthesia

Intervention Type PROCEDURE

spinal anesthesia using the surface landmark-guided

Ultrasonography Group

patients will receive spinal anesthesia after us-assisted technique

Group Type EXPERIMENTAL

spinal anesthesia

Intervention Type PROCEDURE

spinal anesthesia after us-assisted technique

Interventions

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spinal anesthesia

spinal anesthesia after us-assisted technique

Intervention Type PROCEDURE

spinal anesthesia

spinal anesthesia using the surface landmark-guided

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Maram Ashraf Zahr Eldeen

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Maram Ashraf Zahr Eldeen, resident doctor

Role: CONTACT

[email protected]
+201222201740

References

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Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):763-771. doi: 10.1097/EJA.0000000000001029.

Reference Type BACKGROUND
PMID: 31188153 (View on PubMed)

Li M, Ni X, Xu Z, Shen F, Song Y, Li Q, Liu Z. Ultrasound-Assisted Technology Versus the Conventional Landmark Location Method in Spinal Anesthesia for Cesarean Delivery in Obese Parturients: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):155-161. doi: 10.1213/ANE.0000000000003795.

Reference Type BACKGROUND
PMID: 30234528 (View on PubMed)

Coviello A, Iacovazzo C, Piccione I, Posillipo C, Barone MS, Ianniello M, de Siena AU, Cirillo D, Vargas M. Impact of Ultrasound-Assisted Method on Success Rate of Spinal Anesthesia Performed by Novice Trainees: A Retrospective Comparative Study. J Pers Med. 2023 Oct 21;13(10):1515. doi: 10.3390/jpm13101515.

Reference Type BACKGROUND
PMID: 37888126 (View on PubMed)

Geng J, Chen XL, Wang XD, Guo XY, Li M. [Ultrasound imaging increases first-attempt success rate of neuraxial block in elderly patients]. Zhonghua Yi Xue Za Zhi. 2016 Nov 22;96(43):3459-3463. doi: 10.3760/cma.j.issn.0376-2491.2016.43.004. Chinese.

Reference Type BACKGROUND
PMID: 27903338 (View on PubMed)

Zhu G, Wang X, Yang L. Real-time ultrasound-guided neuraxial anesthesia for cesarean section in parturients with previous internal fixation surgery for lumbar fracture: a case series. Quant Imaging Med Surg. 2023 Jan 1;13(1):529-535. doi: 10.21037/qims-22-223. Epub 2022 Oct 26. No abstract available.

Reference Type BACKGROUND
PMID: 36620151 (View on PubMed)

Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.

Reference Type BACKGROUND
PMID: 24141882 (View on PubMed)

Feng Q, Zhang L, Zhang M, Wen Y, Zhang P, Wang Y, Zeng Y, Wang J. Morphological parameters of fourth lumbar spinous process palpation: a three-dimensional reconstruction of computed tomography. J Orthop Surg Res. 2020 Jun 22;15(1):227. doi: 10.1186/s13018-020-01750-2.

Reference Type BACKGROUND
PMID: 32571368 (View on PubMed)

Other Identifiers

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landmark VS US guided

Identifier Type: -

Identifier Source: org_study_id