NCT03486548

Brief Summary

This study evaluate the efficacy of adding popliteal sciatic nerve block with low concentration bupivacaine and dexamethasone to abductor canal block for total knee arthroplasty in patient with NSAIDs prescribing precaution. Half of participants will receive popliteal sciatic nerve block, abductor canal block and periarticular injection, while the other half will receive a sham block, abductor canal block and periarticular injection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 15, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

March 15, 2018

Last Update Submit

April 2, 2018

Conditions

Total Knee ArthroplastyAdductor Canal BlockSciatic Nerve Block

Keywords

popliteal sciatic nerve blocktotal knee artgroplastyadductor canal blockdexamethasone

Outcome Measures

Primary Outcomes (1)

  • postoperative pain score at rest

    postoperative pain score at rest at 24 hour

    postoperative 24 hours

Secondary Outcomes (7)

  • postoperative pain score at anterior and posterior site of knee

    postoperative 24 hours

  • postoperative pain score on 45 degree knee flexion and physical therapy

    postoperative 24 hours

  • level of tibialis anterior muscle weakness

    postoperative 24 hours

  • adverse events

    postoperative 24 hours

  • total morphine consumption in postoperative 24 hours

    postoperative 24 hours

  • +2 more secondary outcomes

Study Arms (2)

control group

SHAM COMPARATOR

adductor canal block with sham block

Drug: bupivacaine and lidocaineDevice: Ultrasound

sciatic group

EXPERIMENTAL

adductor canal block with popliteal sciatic nerve block

Drug: bupivacaine and dexamethasoneDevice: Ultrasound

Interventions

bupivacaine and dexamethasoneDRUG

adductor canal block with 0.33% bupivacaine 15 ml with ultrasound guided popliteal sciatic block with 0.125% bupivacaine 20 ml and dexamethasone 5 mg

Also known as: bupivacaine
sciatic group
bupivacaine and lidocaineDRUG

adductor canal block with 0.33% bupivacaine 15 ml with ultrasound at popliteal sciatic area and subcutaneous infiltration popliteal area with 2% lidocaine 1 ml

control group
UltrasoundDEVICE

ultrasound

control groupsciatic group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient scheduled for single total knee arthroplasty
  • patient with NSAIDs prescribing precautions such as history of NSAIDs allergy, Chronic kidney disease (GFR\< 50 ml/min), history of ischemic heart disease or cerebrovascular disease

You may not qualify if:

  • patient refusal
  • body weight less than 45 kg
  • history of allergy to bupivacaine or dexamethasone
  • uncontrolled diabetes mellitus
  • contraindicated for spinal block, adductor canal block or sciatic nerve block
  • inability to assess pain score (cognitive or psychiatric history)
  • patient scheduled for revision TKA
  • preexisting neuropathy or neurological deficit in lower extremity
  • preexisting chronic pain (prolonged use of oral morphine 20 mg/day or equivalent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Sirivanasandha B, Sutthivaiyakit K, Kerdchan T, Poolsuppasit S, Tangwiwat S, Halilamien P. Adding a low-concentration sciatic nerve block to total knee arthroplasty in patients susceptible to the adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs): a randomized controlled trial. BMC Anesthesiol. 2021 Nov 13;21(1):282. doi: 10.1186/s12871-021-01491-7.

    PMID: 34773995DERIVED

MeSH Terms

Interventions

BupivacaineDexamethasoneLidocaineUltrasonography

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Busara Sirivanasandha, MD

    Department of Anesthesia, Siriraj hospital, Mahidol university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Busara Sirivanasandha, MD

CONTACT

+6624197995busarasiri@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2018

First Posted

April 3, 2018

Study Start

April 1, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

April 3, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)