NCT03410888

Brief Summary

Study Hypothesis The investigators approach to demonstrate noninferiority of analgesia provided by popliteal block in TKA surgery will be based on a hypothesis of absence of a clinically significant difference in pain visual analogue sores (VAS) between the analgesia provided by the popliteal block and that of the infragluteal sciatic block in TKA surgery patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
5 years until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

February 11, 2013

Last Update Submit

January 18, 2018

Conditions

Neuromuscular Blockade

Keywords

sciatic nerve blockinfragluteal approachpopliteal approach

Outcome Measures

Primary Outcomes (1)

  • Visual analogue pain scores. The score at 6 hours will be considered as primary outcome.

    Overall pain level as well as pain localized o the back of the knee will be assessed at rest and on movement (knee flexion) and will be quantified with a 100 mm VAS pain scale score, with 0 representing no pain and 100 representing the worst imaginable pain.

    6 hours

Secondary Outcomes (1)

  • Sensory/Motor block onset assesment in the sciatic nerve distribution

    60 minutes

Study Arms (2)

popliteal approach

EXPERIMENTAL

Blockade of the sciatic nerve at the level of the popliteal fossa.

Procedure: Popliteal approach

infragluteal approach

ACTIVE COMPARATOR

Blocking the sciatic nerve at the subgluteal level.

Procedure: Infragluteal approach

Interventions

Popliteal approachPROCEDURE

Popliteal approach: Under ultrasound guidance a 50 to 90 mm 22 G needle is inserted in and advanced to contact the target nerve until nerve movement is detected. The end point of nerve block in this group is obtaining a circumferential local anesthetic spread around the sciatic nerve.

popliteal approach
Infragluteal approachPROCEDURE

Infragluteal approach: 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 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 approach

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • American Society of Anesthesiologists (ASA) Physical Status Scale 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 or failure to institute spinal anesthesia after performing femoral and sciatic blocks
  • Bilateral TKA surgeries
  • History of significant psychiatric conditions that may affect patient assessment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (3)

  • 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: 9661553BACKGROUND

  • 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: 12934209BACKGROUND

  • Bailey SL, Parkinson SK, Little WL, Simmerman SR. Sciatic nerve block. A comparison of single versus double injection technique. Reg Anesth. 1994 Jan-Feb;19(1):9-13.

    PMID: 8148303BACKGROUND

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

January 25, 2018

Study Start

August 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

CA(1)