NCT03427385

Brief Summary

The purpose of this study is to determine the minimum dose of ropivacaine 0.5%, required to produce pain relief without weakening the leg muscles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration 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

September 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2014

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

January 26, 2018

Last Update Submit

February 8, 2018

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • Tolerance to Transcutaneous Electrical Stimulation (TES)

    To determine the minimum effective dose of ropivacaine in the adductor canal block to initiate sensory analgesia in the knee. Complete sensory anesthesia in the knee following adductor canal block 30 minutes after ropivacaine administration.

    30 min after ropivacaine injection

Secondary Outcomes (2)

  • The degree of motor block following ropivacaine administration

    Assessments will start at baseline before ropivacaine injection and every 5 minutes after ropivacaine injection until 45 minutes have passed or until surgery commences, whichever comes first

  • Cold sensation

    30 min after ropivacaine injection

Other Outcomes (1)

  • Total opioid consumption

    48 hours

Study Arms (1)

Minimum Effective dose

EXPERIMENTAL

Local anesthetic Ropivacaine 0.5% injection for adductor canal block

Drug: Ropivacaine 0.5%

Interventions

Ropivacaine 0.5%DRUG

The volume of local anesthetic Ropivacaine 0.5% will be determined by the response (success or failure of block, 30 minutes after local anesthetic injection) of the previous patient in that group. Block success is defined as an absence of ice sensation in the knee within 30 min of ropivacaine administration accompanied by tolerance to tetanic electrical stimulation (TES) at 60 mA(milliamp) for 5 seconds.

Also known as: Naropin
Minimum Effective dose

Eligibility Criteria

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

You may qualify if:

  • ASA(American Society of Anesthesiologists)physical status classification system I-III
  • years of age, inclusive
  • BMI 18 - 40
  • Scheduled for elective total knee replacement under spinal anesthesia or general anesthesia.

You may not qualify if:

  • Inability or refusal to provide informed consent
  • Any contraindication to regional anesthesia (allergy to local anesthetics, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (5)

  • Krombach J, Gray AT. Sonography for saphenous nerve block near the adductor canal. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):369-70. doi: 10.1016/j.rapm.2007.04.006. No abstract available.

    PMID: 17720129BACKGROUND

  • Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. doi: 10.1093/bja/aem100. Epub 2007 May 3.

    PMID: 17478453BACKGROUND

  • Danelli G, Ghisi D, Fanelli A, Ortu A, Moschini E, Berti M, Ziegler S, Fanelli G. The effects of ultrasound guidance and neurostimulation on the minimum effective anesthetic volume of mepivacaine 1.5% required to block the sciatic nerve using the subgluteal approach. Anesth Analg. 2009 Nov;109(5):1674-8. doi: 10.1213/ANE.0b013e3181b92372.

    PMID: 19843807BACKGROUND

  • Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available.

    PMID: 19901788BACKGROUND

  • Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.

    PMID: 19916251BACKGROUND

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Vincent WS Chan, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Richard Brull, MD

    University Health Network, Toronto

    STUDY CHAIR

  • Ki Jinn Chin, MD

    University Health Network, Toronto

    STUDY CHAIR

  • Anahi Perlas, MD

    University Health Network, Toronto

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 9, 2018

Study Start

September 1, 2012

Primary Completion

August 5, 2014

Study Completion

August 5, 2014

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

CA(1)