NCT04445480

Brief Summary

Endovascular revascularization is an effective procedure in treatment of chronic critical limb ischemia. The less invasive procedure in high risk patients produce the benefit to the patients. However, some of the patients cannot tolerate local anaesthesia. These patients need sedation or even general anaesthesia, which increase unnecessary risk to the patients. This study is conducted to evaluate the benefit of popliteal sciatic nerve block or popliteal block compare to sedation in critical limb patients undergoing angioplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

March 4, 2020

Last Update Submit

June 22, 2020

Conditions

AngioplastyAnaesthesia and Analgesia

Keywords

popliteal blockchronic limb ischemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of general anaesthesia

    Five hours

Secondary Outcomes (1)

  • Numerical pain rating scale during procedure

    Five hours

Study Arms (2)

Popliteal block group

EXPERIMENTAL
Procedure: Popliteal block

Control group

ACTIVE COMPARATOR
Other: Control

Interventions

Popliteal blockPROCEDURE

Sciatic nerve block at popliteal fossa would perform before the participant undergoing angioplasty in experimental arm.

Popliteal block group
ControlOTHER

Sciatic nerve at popliteal fossa would be scanned with the ultrasound. The toothpick would be applied to simulate the procedure of nerve block.

Control group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 20 year-old with chronic ischemic limb pain
  • Scheduled for peripheral angioplasty under monitor anaesthesia care
  • Expected timing of procedure not more than 3 hours

You may not qualify if:

  • Age less than 21
  • Cannot cooperate with the staff
  • Having pain in other areas or both legs
  • Contraindicate for nerve block
  • Allergy to local anesthetic drugs or sedative drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology department, Siriraj Hospital, Mahidol University

Bangkok, Thailand

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

June 24, 2020

Study Start

May 7, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

TH(1)