Effects of Thoracic Paravertebral Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS) - A Randomized, Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative chronic pain scores (VAS) at rest and during mobilization
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patient Controlled Analgesia (IV PCA)
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
Intervention: Patient Controlled Analgesia (IV PCA) (Drug)
Thoracic Paravertebral Block (TPVB)
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)
Intervention: Thoracic paravertebral block (TPVB) (Drug)
Outcomes
Primary Outcomes
Postoperative chronic pain scores (VAS) at rest and during mobilization
Time Frame: Up to 6 months
Chronic pain follow-up
Secondary Outcomes
- Postoperative vital signs(0-48 hours)
- Postoperative acute pain at rest and during coughing/mobilization(0-48 hours)
- Postoperative nausea and vomiting (PONV) and antiemetic requirements(0-48 hours)
- Postoperative morphine consumption(0-48 hours)
- Time to first analgesic(0-48 hours)
- Postoperative first oral intake, flatulence, defecation, mobilization times(0-48 hours)
- 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(Up to 6 months)
Investigators
Nuzhet Mert Senturk, MD, Prof
MD, Prof. Dr
Istanbul University