Clinical trial NCT02658058: Pre-procedural Ultrasound Techniques Versus Conventional Landmark Technique of Spinal Anesthesia in Elderly Patients
Official title: A Randomized Controlled Trial of Pre-procedural Ultrasound Techniques Versus the Conventional Landmark Technique of Spinal Anesthesia in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Ultrasound
Spinal anesthesia
Elderly
Landmark
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Traditionally, spinal anesthesia is performed using the palpation of bony landmark to identify the level and point of entry of the spinal needle. Recently, ultrasound imaging has become an increasingly popular procedure among anesthesiologists to guide neuraxial blockade. Most of the studies on pre-procedural ultrasound-guided neuraxial techniques are limited to a midline approach using a transverse median views. The parasagittal oblique view consistently offers better ultrasound view of the neuraxis compared to the transverse median view. However, it is still not evident whether these superior parasagittal oblique views will lead to an easier paramedian needle insertion. In the literature, there are no studies directly comparing the US-guided paramedian approach using the parasagittal oblique (PSO) view, the US-guided midline approach using the transverse median view, and the conventional landmark midline approach to perform spinal anesthesia in the elderly patients, in particular for the teaching of novice anesthesia residents.

Detailed description: The aim of this study is to find out the optimal technique to perform spinal anesthesia by residents in training. Thus the investigators will compare preprocedural ultrasound-guided paramedian technique using parasagittal oblique view vs preprocedural ultrasound-guided midline technique using transverse median view vs landmark-guided midline technique of spinal anesthesia in the elderly population. Our hypothesis is that both preprocedural US-guided techniques are superior to the conventional landmark-guided midline technique with regard to ease of performance defined as success rate at first attempt, number of puncture attempts, spinal procedure time, and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for surgery amenable to spinal anesthesia, aged more than 60 years, with American Society of Anesthesiologists physical status 1 to 4.

Exclusion Criteria:

* Patients who are unable to give consent, refuse spinal anesthesia, have spinal abnormalities (including scoliosis and previous spine operations with instrumentation) or have contraindications to spinal anesthesia, including allergy to local anesthetics or a bleeding diathesis

Primary outcomes:
measure: Rate of successful dural puncture on the first needle insertion attempt
timeFrame: up to 5 minutes from the start of insertion of the introducer of the spinal needle
Secondary outcomes:
measure: overall success rate in every technique
timeFrame: 60 minutes from the start of insertion of introducer of the spinal needle
measure: Number of introducer needle insertion attempts
timeFrame: 45 minutes from the start of insertion of introducer of the spinal needle
measure: spinal procedure time
timeFrame: 60 minutes
measure: patient satisfaction
timeFrame: 5 min after completion of administration of SA:
measure: Number of spinal needle redirections
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical center
Study officials:
affiliation: American University of Beirut Medical Center
name: Sahar Siddik-Sayyid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rizk MS, Zeeni CA, Bouez JN, Bteich NJ, Sayyid SK, Alfahel WS, Siddik-Sayyid SM. Preprocedural ultrasound versus landmark techniques for spinal anesthesia performed by novice residents in elderly: a randomized controlled trial. BMC Anesthesiol. 2019 Nov 11;19(1):208. doi: 10.1186/s12871-019-0882-8.