Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS) (VATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02302586
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
Nuzhet Mert Senturk, MD, Prof, Istanbul University

Tracking Information
First Submitted Date  ICMJE November 20, 2014
First Posted Date  ICMJE November 27, 2014
Last Update Posted Date August 3, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
Postoperative chronic pain scores (VAS) at rest and during mobilization [ Time Frame: Up to 6 months ]
Chronic pain follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
  • Postoperative vital signs [ Time Frame: 0-48 hours ]
    Postoperative early period hemodynamic follow-up
  • Postoperative acute pain at rest and during coughing/mobilization [ Time Frame: 0-48 hours ]
    Postoperative acute pain score (VAS) follow-up
  • Postoperative nausea and vomiting (PONV) and antiemetic requirements [ Time Frame: 0-48 hours ]
    Postoperative acute PONV and antiemetic use follow-up
  • Postoperative morphine consumption [ Time Frame: 0-48 hours ]
    Postoperative IV PCA morphine consumption for Group 1 and IV morphine consumption for Group 2 as rescue analgesic
  • Time to first analgesic [ Time Frame: 0-48 hours ]
    Postoperative first analgesic IV PCA morphine demand time for Group 1 and first rescue analgesic IV morphine time for Group 2
  • Postoperative first oral intake, flatulence, defecation, mobilization times [ Time Frame: 0-48 hours ]
    Postoperative first oral intake, flatulence, defecation, mobilization times
  • Postoperative hospital discharge day and time [ Time Frame: Participants is being followed for the duration of hospital stay, an expected average of 1 week ]
    Postoperative hospital discharge day and time
  • Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up [ Time Frame: Up to 6 months ]
    Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up with phone call
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)
Official Title  ICMJE Effects of Thoracic Paravertebral Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS) - A Randomized, Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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
    Other Name: Bupivacaine
  • Drug: 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
    Other Name: Morphine
Study Arms  ICMJE
  • Active Comparator: 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: Drug: Patient Controlled Analgesia (IV PCA)
  • Active Comparator: 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: Drug: Thoracic paravertebral block (TPVB)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2017)
60
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2014)
40
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02302586
Other Study ID Numbers  ICMJE 46143867-1035
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nuzhet Mert Senturk, MD, Prof, Istanbul University
Study Sponsor  ICMJE Istanbul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mert N Senturk, Prof MD, Prof
PRS Account Istanbul University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP