Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain

NCT ID: NCT03632161

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-04-15

Brief Summary

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

Detailed Description

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Most Video-Assisted Throcoscopy Surgery (VATS) procedures are considered low-risk interventions requiring short hospital stays or even outpatient settings. Because of these factors, VATS did not raise as much interest as thoracotomy in its postoperative pain management. However, it is a fact that pain following VATS can be severe and long-lasting .According to Richardson and colleagues, 38% of VATS procedures present persistent pain two months after surgery as a result of acute nerve damage during the surgical procedure.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexmedetomidine

Dexmedetomidine is added to bupivacaine the paravertebral block

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Bupivacaine

Bupivacaine only in the paravertebral block

Group Type OTHER

Bupivacaine

Intervention Type DRUG

isobaric bupivacaine 0.5% (0.3ml/kg)

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Bupivacaine

isobaric bupivacaine 0.5% (0.3ml/kg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patient refusal
* Allergy to medication
* Coagulopathy
* Malformation
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Emad Zarief , MD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Emad Zarief Kamel Said

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 31151335 (View on PubMed)

Other Identifiers

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IRB00009920

Identifier Type: -

Identifier Source: org_study_id

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