Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)

Thoracic Clinical Trial

Official title:

Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04208542
• Other study ID #: 4-2019-0050
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Yonsei University
• Contact: Sang Jun Park
• Phone: 82-2-2228-2405
• Email: iotas[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized study intended to assess the efficacy of erector spinae plane analgesia on acute and chronic postoperative pain for VATS procedures. It will include 72 patients presenting to Severance hospital for a VATS procedure. Patients will be randomized 1:1 to receive either ESP block and intravenous patient-controlled analgesia (IV PCA) or IV PCA only. Ropivacaine will be used in nerve block, and injected at the end of surgery. The primary outcome will be to compare analgesic efficacy between the two groups as defined by immediate postoperative pain scores on the numeric pain rating scale. Secondary outcomes include total opioid consumption, painDETECT score, and chronic pain scores.

Description:

Postoperative pain control for thoracic surgery is key to allow faster recovery and diminish postoperative complications. Poorly controlled acute pain may contribute to the impairment of respiratory function and the development of chronic post-thoracotomy pain.

Recently, an increasing number of erector spinae plane (ESP) nerve blocks are being performed as it has been demonstrated, and via case reports that the blocks provide clinical effectiveness, but may have a better side-effect profile than the paravertebral nerve block and epidural analgesia. Moreover, there is an advantage for novice because ESP block is simpler and safer to proceed than conventional nerve blocks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male and Female participants providing written informed consent,

2. ASA grade 1-3,

3. aged over 20 and under 80,

4. primary lung cancer participants scheduled segmentectomy or lobectomy c MLND,

5. undergoing a VATS procedure under General Anaesthesia

Exclusion Criteria:

1. Absence of informed written consent,

2. chemotherapy before or after surgery,

3. pre existing infection at block site,

4. severe coagulopathy,

5. pre existing neurological deficit,

6. previous history of opiate abuse,

7. pregnancy,

8. pre existing chronic pain condition,

Related Conditions & MeSH terms

• Chronic Pain
• Thoracic

Intervention

Drug:
• ESP block
Ultrasound guided Erector spinae block (ESP) will perform.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating scale (NRS)	These scores will record till the postoperative 48 hours.; - The Numerical Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).	up to postoperative 48 hours.
Secondary	opioid consumption	Total opioid consumption will calculate and record till the postoperative 48th hours.	postoperative 48th hours
Secondary	opioid consumption	Total opioid consumption will calculate and record till the postoperative 3 months after surgery.	3 months after surgery.
Secondary	postoperative painDETECT score	painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain.	up to postoperative 3 months.
Secondary	NRS	NRS will record at postoperative 3 months.; - The Numerical Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).	up to postoperative 3 months.