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Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Bupivacaine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal
  • Allergy to medication
  • Coagulopathy
  • Malformation

Sites / Locations

  • Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Dexmedetomidine

Bupivacaine

Arm Description

Dexmedetomidine is added to bupivacaine the paravertebral block

Bupivacaine only in the paravertebral block

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

chronic post thoracic surgery pain
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

Full Information

First Posted
August 9, 2018
Last Updated
August 19, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03632161
Brief Title
Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain
Official Title
Para-Vertebral Dexmedetomidine in Video-Assisted Thoracic Surgeries for Acute and Chronic Pain Prevention; A Randomized Double Blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
January 23, 2018 (Actual)
Study Completion Date
April 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Dexmedetomidine is added to bupivacaine the paravertebral block
Arm Title
Bupivacaine
Arm Type
Other
Arm Description
Bupivacaine only in the paravertebral block
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
isobaric bupivacaine 0.5% (0.3ml/kg)
Primary Outcome Measure Information:
Title
acute postoperative pain
Description
assessment of pain by visual analog scale (VAS) by cm with minimal =0 and maximal =10, worst pain mean scale of 10
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
chronic post thoracic surgery pain
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA II-III Adult Video-assisted thoracic surgery Exclusion Criteria: Patient refusal Allergy to medication Coagulopathy Malformation
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31151335
Citation
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.
Results Reference
derived

Learn more about this trial

Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain

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