Real-Time Ultrasound-guidance Facilitates Paramedian Spinal Anaesthesia

NCT02830035 | Completed

• 1 other identifier: USM/JEPeM/283.2.(5)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the clinical efficacy of real-time ultrasound guidance on spinal anesthesia vs the traditional anatomical landmark technique, by comparing success rate of spinal needle insertion, success rate rate of single needle pass, duration and immediate complications.

Conditions

Wounds and Injuries

Keywords

ultrasound guided; spinal anesthesia; neuraxial block; paramedian

Outcome Measures

Primary Outcomes (2)

• success rate of spinal needle insertion

  The ability of getting a successful spinal anesthesia with a single skin puncture regardless of needle redirection.

  during the procedure of spinal anesthesia

• success rate of single needle pass

  The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.

  during the procedure of spinal anesthesia

Secondary Outcomes (2)

• duration of procedure

  during the procedure of spinal anesthesia

• immediate complication

  immediately after and within 1 week after given spinal anesthesia

Study Arms (2)

Anatomical Landmark Technique

ACTIVE COMPARATOR

Traditional anatomical landmark technique based paramedian spinal anesthesia

Procedure: Anatomical Landmark Technique

Real-time Ultrasound-guided Technique

ACTIVE COMPARATOR

Ultrasound-guided paramedian spinal anesthesia Intervention: Ultrasound-guided Technique

Procedure: Real-time Ultrasound-guided

Interventions

Real-time Ultrasound-guided PROCEDURE

Real-time ultrasound guided paramedian spinal anesthesia

Real-time Ultrasound-guided Technique

Anatomical Landmark Technique PROCEDURE

Conventional anatomical landmark technique for paramedian spinal anesthesia

Anatomical Landmark Technique

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consented adults aged at least 18 years old.
• ASA I to III.
• Presented for lower limb surgery.
• Fasted for at least 6 hours.

You may not qualify if:

• Patient refusal
• Contraindication to neuraxial block.
• Patient on anticoagulant medication, or coagulopathy (INR \> 1.5)
• Patient on double antiplatelet, or thrombocytopenia (platelet \< 100)
• Local infection at site of injection
• Indeterminate neurological disease
• Allergy to local anaesthetics
• Spinal abnormality
• Pregnancy.
• Previous surgery to lumbar region.
• BMI \> 30

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (8)

• Niazi AU, Chin KJ, Jin R, Chan VW. Real-time ultrasound-guided spinal anesthesia using the SonixGPS ultrasound guidance system: a feasibility study. Acta Anaesthesiol Scand. 2014 Aug;58(7):875-81. doi: 10.1111/aas.12353. Epub 2014 Jun 18.

  PMID: 24943307 BACKGROUND

• Ansari T, Yousef A, El Gamassy A, Fayez M. Ultrasound-guided spinal anaesthesia in obstetrics: is there an advantage over the landmark technique in patients with easily palpable spines? Int J Obstet Anesth. 2014 Aug;23(3):213-6. doi: 10.1016/j.ijoa.2014.03.001. Epub 2014 Mar 12.

  PMID: 24768303 BACKGROUND

• Grau T, Leipold RW, Fatehi S, Martin E, Motsch J. Real-time ultrasonic observation of combined spinal-epidural anaesthesia. Eur J Anaesthesiol. 2004 Jan;21(1):25-31. doi: 10.1017/s026502150400105x.

  PMID: 14768920 BACKGROUND

• Horlocker TT, Wedel DJ, Benzon H, Brown DL, Enneking FK, Heit JA, Mulroy MF, Rosenquist RW, Rowlingson J, Tryba M, Yuan CS. Regional anesthesia in the anticoagulated patient: defining the risks (the second ASRA Consensus Conference on Neuraxial Anesthesia and Anticoagulation). Reg Anesth Pain Med. 2003 May-Jun;28(3):172-97. doi: 10.1053/rapm.2003.50046. No abstract available.

  PMID: 12772135 BACKGROUND

• Wang Q, Yin C, Wang TL. Ultrasound facilitates identification of combined spinal-epidural puncture in obese parturients. Chin Med J (Engl). 2012 Nov;125(21):3840-3.

  PMID: 23106885 BACKGROUND

• Conroy PH, Luyet C, McCartney CJ, McHardy PG. Real-time ultrasound-guided spinal anaesthesia: a prospective observational study of a new approach. Anesthesiol Res Pract. 2013;2013:525818. doi: 10.1155/2013/525818. Epub 2013 Jan 10.

  PMID: 23365568 BACKGROUND

• Brinkmann S, Tang R, Sawka A, Vaghadia H. Single-operator real-time ultrasound-guided spinal injection using SonixGPS: a case series. Can J Anaesth. 2013 Sep;60(9):896-901. doi: 10.1007/s12630-013-9984-9. Epub 2013 Jun 19.

  PMID: 23780883 BACKGROUND

• Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.

  PMID: 21572316 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Soon Eu Chong, MD, MMed

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

• Mohd Nikman Ahmad, MD, MMed

  Universiti Sains Malaysia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Lecturer in Anesthesiology

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 12, 2016
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

MY (1)