Persistent Pain Induced by Uniportal Video-assisted Thoracic Surgery

Post-thoracotomy Pain Syndrome Clinical Trial

Official title:

A Prospective Study of Persistent Pain Induced by Uniportal Video-assisted Thoracic Surgery: Incidence, Diagnosis, and Intercostal Nerve Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05379816
• Other study ID #: 202108162RINA
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: National Taiwan University Hospital
• Contact: Wen-ying Lin, Dr.
• Phone: 0972652006
• Email: ying434[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators investigate the prevalence of PTPS in patients receiving with uniportal video-assisted thoracic surgery (VATS), and early identify neuropathic pain as well as treated with neural protective strategy to target intercostal nerve.

Description:

More than 30% of patients have persistent pain after thoracic surgery. Intercostal neuralgia is characterized by neuropathic pain in the distribution of affected intercostal nerve(s) (along the ribs, chest, or abdomen) that commonly manifests as a sharp, aching, radiating, burning, or stabbing pain and may be associated with paresthesia such as numbness and tingling. The pain may be intermittent or constant and typically presents as a band-like pain that is wrapped around the chest and back or in a thoracic dermatomal pattern. Pain may last for a prolonged period and may continue long after the disease process has subsided.

Hypertonic dextrose injection (prolotherapy) is reported to reduce pain, including non-surgical chronic low back pain (CLBP), and subcutaneous injection of 5% dextrose is said to minimize neurogenic pain hyperalgesia and allodynia. The mechanism in both cases is unclear, though a direct effect of dextrose on neurogenic pain has been proposed. This study assessed the short-term analgesic effects of epidural 5% dextrose injection compared with saline for non-surgical CLBP.

Intercostal nerve damage is a suspected pathogenic mechanism for developing post-thoracotomy pain syndrome (PTPS). Video-assisted thoracic surgery (VATS) is a minimally invasive procedure that potentially reduces PTPS. However, there was no specific outcome study for uniportal VATS.

In this study, the investigators investigate the prevalence of PTPS in patients receiving uniportal video-assisted thoracic surgery (VATS), identify neuropathic pain early, and treat it with a neural protective strategy to target intercostal pain nerve.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• PTPS after single port VATS

Exclusion Criteria:

• abnormal sensation

• can not complete questionnaire

• others cause of pain

Related Conditions & MeSH terms

• Post-thoracotomy Pain Syndrome

Intervention

Procedure:
• 5% DW perineural injection
5% DW perineural injection to intercostal nerve

Locations

Country	Name	City	State
Taiwan	National taiwan university cancer center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	difference of Numerical rating scale, before and after	3 months
Secondary	Quantitative sensory test	difference of cold, warm, tactile detection threshold, before and after	3 months