Thoracic
Conditions
Keywords
Thoracic surgical procedures
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.
Interventions
DRUGESP block
Ultrasound guided Erector spinae block (ESP) will perform.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Both participants and anesthesia provider will not know which intervention applied. Another anesthesia provider who did not perform nerve block will follow and record to the study data.
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| opioid consumption | postoperative 48th hours | Total opioid consumption will calculate and record till the postoperative 48th hours. |
| 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). |
Countries
South Korea
Contacts
Primary ContactSang Jun Park
Outcome results
None listed