Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain

August 19, 2018 updated by: Emad Zarief , MD, Assiut University

Para-Vertebral Dexmedetomidine in Video-Assisted Thoracic Surgeries for Acute and Chronic Pain Prevention; A Randomized Double Blinded Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Emad Zarief Kamel Said

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal
  • Allergy to medication
  • Coagulopathy
  • Malformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine
Dexmedetomidine is added to bupivacaine the paravertebral block
Drug: Dexmedetomidine
isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg)
Other: Bupivacaine
Bupivacaine only in the paravertebral block
Drug: Bupivacaine
isobaric bupivacaine 0.5% (0.3ml/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute postoperative pain
Time Frame: 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
chronic post thoracic surgery pain
Time Frame: 3 months
Chronic neuropathic pain was assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale with non-neuropathic pain if the scale <12, and neuropathic pain is likely to be the contributing cause of pain if the scale >12
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

January 23, 2018

Study Completion (Actual)

April 15, 2018

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 19, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00009920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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