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

NCT06707571 | Not Yet Recruiting DMC

• 1 other identifier: landmark VS US guided
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer Surgery

Keywords

US-guided spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• the first-pass success rate of Combined spinal-epidural anesthesia

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

  baseline

Study Arms (2)

Landmark Group

EXPERIMENTAL

patients will receive spinal anesthesia using the surface landmark-guided

Procedure: spinal anesthesia

Ultrasonography Group

EXPERIMENTAL

patients will receive spinal anesthesia after us-assisted technique

Procedure: spinal anesthesia

Interventions

spinal anesthesia PROCEDURE

spinal anesthesia after us-assisted technique

Ultrasonography Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 31188153 BACKGROUND

• 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.

  PMID: 30234528 BACKGROUND

• 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.

  PMID: 37888126 BACKGROUND

• 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.

  PMID: 27903338 BACKGROUND

• 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.

  PMID: 36620151 BACKGROUND

• 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.

  PMID: 24141882 BACKGROUND

• 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.

  PMID: 32571368 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Maram Ashraf Zahr Eldeen, resident doctor

CONTACT

+201222201740; maramashraf493@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia, Intensive Care and Pain Management Department South Egypt cancer Institute

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 27, 2024

Record last verified: 2024-11