NCT04325113

Brief Summary

Check analgesia after tonsillectomy in adults

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

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

February 7, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

March 24, 2020

Last Update Submit

March 26, 2020

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • Patient's satisfaction and pain score

    patient satisfaction and pain score using a visual anagogic scale from 0 (no pain) to 10 (intolerable pain)

    until 10 days after the tonsillectomy.

Study Arms (3)

NaCl 0,9%

PLACEBO COMPARATOR

patients receive 5ml of NaCl 0,9% at the level of the tonsils lodge

Drug: levobupivacaine

Xylocaine 2%

ACTIVE COMPARATOR

patients receive 5ml of Xylocaïne 2% at the level of the tonsils lodge

Drug: levobupivacaine

Levobupivacaine 0,5%

ACTIVE COMPARATOR

patients receive 5ml of Levobupivacaine 0,5% at the level of the tonsils lodge

Drug: levobupivacaine

Interventions

levobupivacaineDRUG

Patient satisfaction and pain score using a visual anagogic scale (VAS)

Also known as: xylocaine, Nacl
Levobupivacaine 0,5%NaCl 0,9%Xylocaine 2%

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Tonsillectomy

You may not qualify if:

  • Gastric or duodenal ulcer
  • Diabetes
  • Kidney failure
  • Chronic pain and fibromyalgia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Javillier

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Agnosia

Interventions

LevobupivacaineLidocaineSodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilidesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 27, 2020

Study Start

February 7, 2019

Primary Completion

December 31, 2019

Study Completion

January 15, 2020

Last Updated

March 27, 2020

Record last verified: 2020-03

Locations

BE(1)