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

Phase 4

• Conditions: Thoracic
• Interventions: Drug: ESP block

• Registration Number: NCT04208542
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	ESP block	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.

Primary Outcome Measures

Name	Time	Method
Numeric rating scale (NRS)	up to postoperative 48 hours.	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).

Secondary Outcome Measures

Name	Time	Method
opioid consumption	3 months after surgery.	Total opioid consumption will calculate and record till the postoperative 3 months after surgery.
postoperative painDETECT score	up to postoperative 3 months.	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.
NRS	up to postoperative 3 months.	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).

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of