Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)

Study Overview
=================
Brief Summary
-----------------
Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which is also a predictor of chronic pain. In this study, the investigators aim to compare the postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.

Detailed Description
-----------------
Video-assisted thoracoscopic surgeries (VATS) include significant postoperative acute and chronic pain because of trocar site tissue damages, intercostal nerve injuries and related inflammatory responses. Poorly controlled pain in the early postoperative period usually causes chronic pain, and also affects patients' physiotherapy, mobilization and daily function. Our hypothesis in this study is 'thoracic paravertebral block (TPVB) is associated with an improvement in control of acute and chronic pain after VATS compared to systemic analgesia.

Official Title
-----------------
Effects of Thoracic Paravertebral Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS) - A Randomized, Clinical Trial

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Thoracic paravertebral block (TPVB)
* Drug: Patient Controlled Analgesia (IV PCA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Patients who undergo Video-assisted thoracoscopic surgery (VATS) under GA Exclusion Criteria: Patients with difficult understanding the instructions for using PCA and/or pain scales Patients with contraindication to regional anesthesia Patients with significant neurologic, psychiatric or cognitive disorders History of substance abuse or chronic opioid use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient Controlled Analgesia (IV PCA)<br>Postoperative intravenous (IV) morphine PCA is being used for acute pain control: Basal infusion: 0.3 mg/kg/h Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg | Drug: Patient Controlled Analgesia (IV PCA)<br>* IV morphine patient controlled analgesia (PCA) is being used in the postoperative period for 48 hours. Basal infusion: 0.3 mg/kg/h, Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg<br>* Other names: Morphine;|
| Active Comparator: Thoracic Paravertebral Block (TPVB)<br>Preoperative thoracic paravertebral block (TPVB) at 4 levels from T4 to T8 is being performed and total of 20 mL Bupivacaine 0.5% is deposited (5 mL per level by using landmark technique) | Drug: Thoracic paravertebral block (TPVB)<br>* Thoracic paravertebral block (TPVB) is being performed by injecting 5 mL of Bupivacaine 0.5% to 4 consecutive level of paravertebral spaces between T4 and T8 by using landmark technique<br>* Other names: Bupivacaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative chronic pain scores (VAS) at rest and during mobilization | Chronic pain follow-up | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative vital signs | Postoperative early period hemodynamic follow-up | 0-48 hours | 
| Postoperative acute pain at rest and during coughing/mobilization | Postoperative acute pain score (VAS) follow-up | 0-48 hours | 
| Postoperative nausea and vomiting (PONV) and antiemetic requirements | Postoperative acute PONV and antiemetic use follow-up | 0-48 hours | 
| Postoperative morphine consumption | Postoperative IV PCA morphine consumption for Group 1 and IV morphine consumption for Group 2 as rescue analgesic | 0-48 hours | 
| Time to first analgesic | Postoperative first analgesic IV PCA morphine demand time for Group 1 and first rescue analgesic IV morphine time for Group 2 | 0-48 hours | 
| Postoperative first oral intake, flatulence, defecation, mobilization times | Postoperative first oral intake, flatulence, defecation, mobilization times | 0-48 hours | 
| Postoperative hospital discharge day and time | Postoperative hospital discharge day and time | Participants is being followed for the duration of hospital stay, an expected average of 1 week | 
| Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up | Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up with phone call | Up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic paravertebral block, Patient controlled analgesia, Video Assisted Thoracoscopic Surgery, Postoperative acute pain, Chronic pain