Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632161
• Other study ID #: IRB00009920
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: August 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 15, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA II-III

• Adult

• Video-assisted thoracic surgery

Exclusion Criteria:

• Patient refusal

• Allergy to medication

• Coagulopathy

• Malformation

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Postoperative

Intervention

Drug:
• Dexmedetomidine
isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg)
• Bupivacaine
isobaric bupivacaine 0.5% (0.3ml/kg)

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3 months