Persistent Pain Induced by Uniportal Video-assisted Thoracic Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-thoracotomy Pain Syndrome
• Intervention / Treatment: Procedure: 5% DW perineural injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen-ying Lin, Dr.; Phone Number: 0972652006; Email: ying434@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 106
    • Recruiting
    • National Taiwan University Cancer Center
    • Contact: Wen-ying Lin, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PTPS after single port VATS

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: conservative treatment; analgesics are used for PTPS
Active Comparator: Interventional treatment; perineural injection	Procedure: 5% DW perineural injection; 5% DW perineural injection to intercostal nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	difference of Numerical rating scale, before and after	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative sensory test	difference of cold, warm, tactile detection threshold, before and after	3 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wen-ying Lin, Dr., National Taiwan University Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 202108162RINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No