Sciatic Nerve Block Using the Subgluteal Space Approach: A Comparison With the Infragluteal Approach

NCT01814605 | Completed

• 1 other identifier: 11-0060-A
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A new ultrasound-guided "subgluteal space" approach to sciatic nerve block that has been recently described obviates the need to identify the sciatic nerve. The investigators hypothesize that the use of an ultrasound-guided subgluteal space injection to perform sciatic nerve block will increase the proportion of patients experiencing complete sensory block in both terminal branches of the Sciatic nerve in comparison to the same proportion in those who receive the block via ultrasound-guided infragluteal approach with circumferential injection in patients scheduled for unilateral TKA(total knee arthroplasty) surgeries.

Conditions

Neuromuscular Blockade

Keywords

Sciatic Nerve Block; Subgluteal space; Infragluteal space

Outcome Measures

Primary Outcomes (1)

• Complete sensory block in the distribution of both terminal branches of the sciatic nerve.

  The independent observer, blinded to the block technique used, will assess patients for sensory and motor block every 5 minutes for 30 minutes or until start of surgery

  up to 30 minutes

Secondary Outcomes (1)

• Block procedure time

  until local anesthetic injection has been completed

Study Arms (2)

Subgluteal space group

EXPERIMENTAL

The patients in Subgluteal space group will receive sciatic block according to the approach described by Karmakar et al. Ultrasound scanning will be used to identify and mark the greater trochanter laterally and the ischial tuberosity medially. The midpoint will be designated with a marker and will be the site of needle entry. A 50 to 90 mm 22 G insulated needle will be inserted at the midpoint previously designated and advanced under real time guidance in an out-of-plane approach until the needle reaches the subgluteal space.

Procedure: Subgluteal space group

Infragluteal space group

ACTIVE COMPARATOR

The patients in this group will receive sciatic bock according to the approach described by Chan et al. Ultrasound scanning will be used to identify and mark the greater trochanter laterally and the ischial tuberosity medially. The midpoint between these two structures is a rough non-binding estimate of the approximate location of the sciatic nerve. After skin and transducer preparation, a curved 5 MHz(megahertz) transducer will be placed over the subgluteal region in a transverse plane to scan the sciatic nerve. A 50 to 90 mm 22 G needle is used and advanced under real time guidance in an out-of-plane approach until the needle tip is adjacent o the nerve.

Procedure: Infragluteal space group

Interventions

Infragluteal space group PROCEDURE

Sciatic Nerve Block "Infragluteal group": Ultrasound scanning will be used to identify and mark the greater trochanter laterally and the ischial tuberosity medially. The midpoint between these two structures is a rough non-binding estimate of the approximate location of the sciatic nerve. The sciatic nerve is usually found anterior (deep) to the gluteus maximus muscle and lateral to the origin of the biceps femoris muscle at the ischial tuberosity as well as medial to the greater trochanter. The end point of nerve block in this group is obtaining a circumferential local anesthetic spread around the sciatic nerve.

Infragluteal space group

Subgluteal space group PROCEDURE

Subgluteal space group: The operator will identify the gluteus maximus and biceps femoris muscles at the level of the greater trochanter and ischial tuberosity and the infragluteal space.

Subgluteal space group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• ASA(American Society of Anesthesiologists physical status classification system) I-III patients undergoing unilateral TKA under spinal anesthesia and nerve blocks
• Ages 18-85
• BMI ≤ 38 Kg/m2

You may not qualify if:

• Chronic pain disorders
• Significant pre-existing neurological deficits or peripheral neuropathy affecting the lower extremity
• Abuse of drugs or alcohol
• Allergies to any medication included in the study protocol
• Contraindication to spinal anesthesia
• History of significant psychiatric conditions that may affect patient assessment
• Pregnancy

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (4)

• Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. doi: 10.1097/00000539-199807000-00020.

  PMID: 9661553 BACKGROUND

• Cook P, Stevens J, Gaudron C. Comparing the effects of femoral nerve block versus femoral and sciatic nerve block on pain and opiate consumption after total knee arthroplasty. J Arthroplasty. 2003 Aug;18(5):583-6. doi: 10.1016/s0883-5403(03)00198-0.

  PMID: 12934209 BACKGROUND

• Weber A, Fournier R, Van Gessel E, Gamulin Z. Sciatic nerve block and the improvement of femoral nerve block analgesia after total knee replacement. Eur J Anaesthesiol. 2002 Nov;19(11):834-6. doi: 10.1017/s0265021502221353. No abstract available.

  PMID: 12442936 BACKGROUND

• Abdallah FW, Chan VW, Koshkin A, Abbas S, Brull R. Ultrasound-guided sciatic nerve block in overweight and obese patients: a randomized comparison of performance time between the infragluteal and subgluteal space techniques. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):547-52. doi: 10.1097/AAP.0000000000000016.

  PMID: 24121610 DERIVED

Study Officials

• Richard Brull, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: March 20, 2013
• Study Start: June 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

CA (1)