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

NCT ID: NCT04208542

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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.

Conditions

Thoracic

Study Design

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

Study Groups

Interventional

Under general anaesthesia, ultrasound guided ESP block will perform at the T5 level with 0.375% ropivacaine 20ml. Fentanyl 1 ug/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with fentanyl (10 ug/kg) and palonosetron 0.075mg will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 48 hours. Pain assessment will record 3 months after surgery.

Group Type: ACTIVE_COMPARATOR

ESP block

Intervention Type: DRUG

Ultrasound guided Erector spinae block (ESP) will perform.

Control

Fentanyl 1 ug/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with fentanyl (10 ug/kg) and palonosetron 0.075mg will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 48 hours. Pain assessment will record 3 months after surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ESP block

Ultrasound guided Erector spinae block (ESP) will perform.

Intervention Type: DRUG

Eligibility Criteria

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,

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Jun Park

Role: CONTACT

iotas@yuhs.ac

82-2-2228-2405

Facility Contacts

Sang Jun Park, MD

Role: primary

iotas@yuhs.ac

82-2-2228-2405

Other Identifiers

4-2019-0050

Identifier Type: -

Identifier Source: org_study_id