NCT02387021

Brief Summary

The purpose of the study is to determine whether the association of sciatic nerve block to continuous adductor canal block is effective in the treatment of total knee arthroplasty post operative pain .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
unknown

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

March 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

March 4, 2015

Last Update Submit

March 7, 2015

Conditions

Neuromuscular BlockadePain Management

Keywords

analgesianerve blockTotal knee replacement

Outcome Measures

Primary Outcomes (1)

  • Total Opioid-consumption

    Cumulative opioid consumption : converting oral, intravenous, and patient-controlled analgesia PCA opioid to morphine equivalent

    8 hours postoperative

Secondary Outcomes (7)

  • NRS pain score at rest

    0,1,2,4,6,8,12,24 and 48 hours postoperative

  • NRS pain score during movement

    0,1,2,4,6,8,12,24 and 48 hours postoperative

  • NRS pain score after 10 meters of walk or maximum walked distance

    8, 24 and 48 hours postoperative

  • Ability to walk

    8, 24 and 48 hours postoperative

  • TUG Test

    8, 24 and 48 hours postoperative

  • +2 more secondary outcomes

Study Arms (2)

Continous femoral nerve block

ACTIVE COMPARATOR

Patients will receive ultrasound-guided (USG) continuous femoral nerve block with 20 ml ropivacaine 0.2% and USG Continuous adductor canal block with 20 ml of saline and USG infragluteal SNB with 20 ml of saline .

Procedure: Continuous femoral nerve blockProcedure: Continuous adductor canal blockProcedure: infragluteal Sciatic nerve blockDrug: Ropivacaine 0.2%Drug: Saline

Continuous adductor canal block

EXPERIMENTAL

Patients will receive ultrasound-guided continuous adductor canal block with 20 ml ropivacaine 0.2% and USG infragluteal SNB with 20 ml ropivacaine 0.2% and USG continuous FNB with 20 ml of saline .

Procedure: Continuous femoral nerve blockProcedure: Continuous adductor canal blockProcedure: infragluteal Sciatic nerve blockDrug: Ropivacaine 0.2%Drug: Saline

Interventions

Continuous femoral nerve blockPROCEDURE
Continous femoral nerve blockContinuous adductor canal block
Continuous adductor canal blockPROCEDURE
Continous femoral nerve blockContinuous adductor canal block
infragluteal Sciatic nerve blockPROCEDURE
Continous femoral nerve blockContinuous adductor canal block
Ropivacaine 0.2%DRUG
Continous femoral nerve blockContinuous adductor canal block
SalineDRUG
Continous femoral nerve blockContinuous adductor canal block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective unilateral TKA,
  • Planned continuous spinal anesthesia ,
  • Ability to follow study protocol,
  • American Society of Anesthesiologists class 1 to 3.

You may not qualify if:

  • Contraindication for neuraxial anesthetic,
  • Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months),
  • Hypersensitivity and/or allergies to any of the study medications,
  • Intraoperative use of volatile anesthetics,
  • Preexisting neuropathy on the operative limb,
  • Contraindications to a femoral, adductor canal or Tibial nerve block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

    PMID: 24401769BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Karim Raies, M.D

CONTACT

+21655208602karim.raies@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 12, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 12, 2015

Record last verified: 2015-03