NCT02049255

Brief Summary

Comparison the use of marcaine and chloroprocaine in rachianesthesia for a surgical correction of inguinal hernia. Comparision between acute and chronic (3 months and 6 months) pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Nov 2013

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

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

11 months

First QC Date

January 24, 2014

Last Update Submit

October 31, 2014

Conditions

Pain

Keywords

All

Outcome Measures

Primary Outcomes (1)

  • Acute pain

    1 day of the surgery when patient leave the recovery room

Secondary Outcomes (1)

  • Chronic pain

    at 3 and 6 months

Study Arms (2)

Marcaine

PLACEBO COMPARATOR

Rachianesthesia with marcaine or chloroprocaine

Drug: Marcaine

Chloroprocaine

ACTIVE COMPARATOR

Rachianesthesia with marcaine or chloroprocaine

Drug: Chloroprocaine

Interventions

ChloroprocaineDRUG

The Group "Chloroprocaine" will receive: Chloroprocaine: 50 mg in rachianesthesia

Chloroprocaine
MarcaineDRUG

The Group "Marcaine" will receive: Marcaine: 12,5 mg in rachianesthesia

Marcaine

Eligibility Criteria

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

You may qualify if:

  • Adults under rachianesthesia

You may not qualify if:

  • Personal history of gastric ulcus
  • ASA 4
  • Emergency
  • Combined surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc Bouge

Bouge, Namur, 5004, Belgium

Location

MeSH Terms

Conditions

PainPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

chloroprocaineBupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Eric P Deflandre, MD, FCCP

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
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
Eric DEFLANDRE, MD, FCCP

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 30, 2014

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

BE(1)