Persistent Pain Induced by Uniportal Video-assisted Thoracic Surgery

NCT ID: NCT05379816

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-03
• Study Completion Date: 2022-12-31

Brief 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.

Detailed 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.

Conditions

Post-thoracotomy Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conservative treatment

analgesics are used for PTPS

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional treatment

perineural injection

Group Type: ACTIVE_COMPARATOR

5% DW perineural injection

Intervention Type: PROCEDURE

5% DW perineural injection to intercostal nerve

Interventions

5% DW perineural injection

5% DW perineural injection to intercostal nerve

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• PTPS after single port VATS

Exclusion Criteria

• abnormal sensation
• can not complete questionnaire
• others cause of pain

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wen-ying Lin, Dr.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

National taiwan university cancer center

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Wen-ying Lin, Dr.

Role: CONTACT

ying434@gmail.com

0972652006

Facility Contacts

Wen-ying Lin, Dr.

Role: primary

Other Identifiers

202108162RINA

Identifier Type: -

Identifier Source: org_study_id