Ultrasound Guided Midline vs Landmark Paramedian Continous Spinal Anesthesia in the Elderly

NCT06740994 | Recruiting

• 1 other identifier: UTEM USSA
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Former clinical studies have reported the superiority of the landmark guided paramedian approach above the classical landmark guided midline approach for the continuous spinal anesthesia especially in the elderly. On the other hand, more recent clinical trials have suggested that the use of ultrasound to guide spinal anesthesia will be safer and more effective than the conventional palpation-guided technique. The aim of this study will be to compare the conventional "blind" landmark paramedian approach to the ultrasound "modern" guided midline approach for the continuous spinal anesthesia in the elderly with hip fractures. Patients will randomly divided into two groups: Group(PML): will undergo conventional landmark guided paramedian continuous spinal anesthesia Group (MUS): will undergo ultrasound guided midline continuous spinal anesthesia

Conditions

Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• the difference in number of needle passes between the two groups

  the number of forward advancements of the Tuohy needle in a given interspinous space (i.e withdrawal and redirection of Tuohy needle without exiting the skin)

  from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin

Secondary Outcomes (6)

• number of spinal needle insertion attempts

  from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin

• the rate of first pass success

  from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin

• time for identifying landmarks

  time taken from start of palpating or ultrasound scanning to the marking of the needle entry point

• time taken for performing continuous spinal anesthesia

  time taken from the start of the first insertion of the needle to the completion of fixation of the catheter to patient skin

• incidence of continuous spinal anesthesia complications

  from the star of first needle insertion to the completion of the continuous spinal anesthesia

Study Arms (2)

paramedian landmark group

EXPERIMENTAL

conventional landmark paramedian approach will be performed. isobar bupivacaine will be injected for continuous spinal anesthesia.

Procedure: conventional landmark paramedian technique

Midline ultrasound group

ACTIVE COMPARATOR

preprocedural ultrasound guided midline approach will be performed. isobar bupivacaine will be injected for continuous spinal anesthesia.

Procedure: preprocedural ultrasound guided midline technique

Interventions

conventional landmark paramedian technique PROCEDURE

a blind landmark scanning will be done and skin marking of the best palpable spinous process will be made. the site of injection will be determined by palpation. continuous spinal anesthesia will be performed via paramedian approach.

Also known as: PML

paramedian landmark group

preprocedural ultrasound guided midline technique PROCEDURE

a preprocedural ultrasound scanning will be done, and skin marking of the best quality space will be made. the site of injection and the insertion angle of the needle will be determined by ultrasound. continuous spinal anesthesia will be performed via midline approach.

Also known as: MUS

Midline ultrasound group

Eligibility Criteria

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

You may qualify if:

• all consented patients aged over 65 years old scheduled to undergo surgery for hip fracture under continuous spinal anesthesia with American Society of Anesthesiologists ASA physical status classification from I to III

You may not qualify if:

• contraindications to spinal anesthesia ( allergy to local anesthetic, coagulopathy, infection at the site of injection)
• previous history of lumbar spine surgery
• per operative severe complication with conversion to general anesthesia

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

BEN ALI MECHAAL, Professor

Nabeul, Mrazga, 8000, Tunisia

RECRUITING

Study Officials

• MECHAAL BEN ALI, Professor

  university manar Tunis, Tunisia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MECHAAL BEN ALI, Professor

CONTACT

72100533; mechaal_benali@yahoo.fr

SAMEH BEN AHMED, Doctor

CONTACT

72100500; sameh.benahmed@fmt.utm.tn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: April 29, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

TU (1)