NCT03038958

Brief Summary

This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side effects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

April 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

January 26, 2017

Last Update Submit

November 15, 2019

Conditions

Knee ArthroscopySpinal Anesthesia

Keywords

Local Anaestheticspinal anesthesiaKnee arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Duration of sensory block

    Total duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block

    Until complete release of sensory block

Secondary Outcomes (5)

  • Onset time of sensory block

    up to 30 minutes

  • Onset time of motor block

    up to 30 minutes

  • Duration of motor block

    Until complete regression of motor block

  • Pain assessed by Visual Analog Scale

    up to 24 hours

  • Side-effects (hypotension, bradycardia, urinary retention)

    up to 24 hours

Study Arms (2)

Isobaric 2-chloroprocaine

ACTIVE COMPARATOR

The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy

Drug: Isobaric 2-chloroprocaine

Hyperbaric prilocaine 2%

ACTIVE COMPARATOR

The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy

Drug: Hyperbaric prilocaine

Interventions

Isobaric 2-chloroprocaineDRUG

intrathecal injection of 50 mg isobaric 2-Chloroprocaine

Also known as: Ampres
Isobaric 2-chloroprocaine
Hyperbaric prilocaineDRUG

intrathecal injection of 50 mg hyperbaric prilocaine 2%

Also known as: Tachipri
Hyperbaric prilocaine 2%

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiology physical status (ASA) ≤ III
  • Age 18-80 year
  • Height between 160 and 185 cm
  • Signed informed consent obtained prior to any study specific assessments and procedures

You may not qualify if:

  • Cardiac pathology (such as Heart failure, Aortic stenosis)
  • Coagulation disorders (INR\>1.3, platelet \< 80 000/mm3)
  • Known allergy to local anaesthetics
  • Disagreement of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Braine-l'Alleud Hospital

Braine-l'Alleud, 1420, Belgium

Location

CHU Saint-Pierre

Brussels Capital Region, 1000, Belgium

Location

Study Officials

  • Emmanuel Guntz, MD

    Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital

    STUDY DIRECTOR

  • Panayota Kapessidou, MD,PhD

    University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 26, 2017

First Posted

February 1, 2017

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)