Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)

Pain, Postoperative Clinical Trial

— VATS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302586
• Other study ID #: 46143867-1035
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2014
• Last updated: August 2, 2017
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2017
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Thoracic paravertebral block (TPVB)
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
• Patient Controlled Analgesia (IV PCA)
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

Locations

Country	Name	City	State
Turkey	Istanbul University, Department of Anesthesiology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative chronic pain scores (VAS) at rest and during mobilization	Chronic pain follow-up	Up to 6 months
Secondary	Postoperative vital signs	Postoperative early period hemodynamic follow-up	0-48 hours
Secondary	Postoperative acute pain at rest and during coughing/mobilization	Postoperative acute pain score (VAS) follow-up	0-48 hours
Secondary	Postoperative nausea and vomiting (PONV) and antiemetic requirements	Postoperative acute PONV and antiemetic use follow-up	0-48 hours
Secondary	Postoperative morphine consumption	Postoperative IV PCA morphine consumption for Group 1 and IV morphine consumption for Group 2 as rescue analgesic	0-48 hours
Secondary	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
Secondary	Postoperative first oral intake, flatulence, defecation, mobilization times	Postoperative first oral intake, flatulence, defecation, mobilization times	0-48 hours
Secondary	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
Secondary	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