Clinical trial NCT02302586: Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)
Official title: Effects of Thoracic Paravertebral Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS) - A Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Thoracic paravertebral block
Patient controlled analgesia
Video Assisted Thoracoscopic Surgery
Postoperative acute pain
Chronic pain
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative chronic pain scores (VAS) at rest and during mobilization
timeFrame: Up to 6 months
Secondary outcomes:
measure: Postoperative vital signs
timeFrame: 0-48 hours
measure: Postoperative acute pain at rest and during coughing/mobilization
timeFrame: 0-48 hours
measure: Postoperative nausea and vomiting (PONV) and antiemetic requirements
timeFrame: 0-48 hours
measure: Postoperative morphine consumption
timeFrame: 0-48 hours
measure: Time to first analgesic
timeFrame: 0-48 hours
measure: Postoperative first oral intake, flatulence, defecation, mobilization times
timeFrame: 0-48 hours
measure: Postoperative hospital discharge day and time
timeFrame: Participants is being followed for the duration of hospital stay, an expected average of 1 week
measure: Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Department of Anesthesiology
Study officials:
affiliation: MD, Prof
name: Mert N Senturk, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Komatsu T, Kino A, Inoue M, Sowa T, Takahashi K, Fujinaga T. Paravertebral block for video-assisted thoracoscopic surgery: analgesic effectiveness and role in fast-track surgery. Int J Surg. 2014;12(9):936-9. doi: 10.1016/j.ijsu.2014.07.272. Epub 2014 Aug 1.