NCT03632161

Brief Summary

Up to our knowledge there is no study focused upon the incidence of post VATS chronic pain when dexmedetomidine is used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

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 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

August 9, 2018

Last Update Submit

August 19, 2018

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • acute postoperative pain

    assessment of pain by visual analog scale (VAS) by cm with minimal =0 and maximal =10, worst pain mean scale of 10

    24 hours

Secondary Outcomes (1)

  • chronic post thoracic surgery pain

    3 months

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine is added to bupivacaine the paravertebral block

Drug: Dexmedetomidine

Bupivacaine

OTHER

Bupivacaine only in the paravertebral block

Drug: Bupivacaine

Interventions

DexmedetomidineDRUG

isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg)

Dexmedetomidine
BupivacaineDRUG

isobaric bupivacaine 0.5% (0.3ml/kg)

Bupivacaine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA II-III
  • Adult
  • Video-assisted thoracic surgery

You may not qualify if:

  • Patient refusal
  • Allergy to medication
  • Coagulopathy
  • Malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

Related Publications (1)

  • Abd-Elshafy SK, Abdallal F, Kamel EZ, Edwar H, Allah EA, Maghraby HHM, Sayed JA, Ali MS, Elkhayat H, Mahran GSK. Paravertebral Dexmedetomidine in Video-Assisted Thoracic Surgeries for Acute and Chronic Pain Prevention. Pain Physician. 2019 May;22(3):271-280.

    PMID: 31151335DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexmedetomidineBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 15, 2018

Study Start

February 1, 2017

Primary Completion

January 23, 2018

Study Completion

April 15, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

EG(1)