Clinical trial NCT04208542: Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)
Official title: Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thoracic
Keywords: Thoracic surgical procedures
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of patients will be studied simultaneously. One group will have the intervention of the ESP block and IV PCA. The other group will have only IV PCA.
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: up to postoperative 48 hours.
Secondary outcomes:
measure: opioid consumption
timeFrame: postoperative 48th hours
measure: opioid consumption
timeFrame: 3 months after surgery.
measure: postoperative painDETECT score
timeFrame: up to postoperative 3 months.
measure: NRS
timeFrame: up to postoperative 3 months.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References: