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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

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Thoracic paravertebral block (TPVB) Drug: Patient Controlled Analgesia (IV PCA) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Thoracic Paravertebral Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS) - A Randomized, Clinical Trial
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
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
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

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)
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




Primary Outcome Measures :
  1. Postoperative chronic pain scores (VAS) at rest and during mobilization [ Time Frame: Up to 6 months ]
    Chronic pain follow-up


Secondary Outcome Measures :
  1. Postoperative vital signs [ Time Frame: 0-48 hours ]
    Postoperative early period hemodynamic follow-up

  2. Postoperative acute pain at rest and during coughing/mobilization [ Time Frame: 0-48 hours ]
    Postoperative acute pain score (VAS) follow-up

  3. Postoperative nausea and vomiting (PONV) and antiemetic requirements [ Time Frame: 0-48 hours ]
    Postoperative acute PONV and antiemetic use follow-up

  4. 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

  5. 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

  6. Postoperative first oral intake, flatulence, defecation, mobilization times [ Time Frame: 0-48 hours ]
    Postoperative first oral intake, flatulence, defecation, mobilization times

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302586


Locations
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Turkey
Istanbul University, Department of Anesthesiology
Istanbul, Turkey, 34093
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Mert N Senturk, Prof MD, Prof

Publications:
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Responsible Party: Nuzhet Mert Senturk, MD, Prof, MD, Prof. Dr, Istanbul University
ClinicalTrials.gov Identifier: NCT02302586    
Other Study ID Numbers: 46143867-1035
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nuzhet Mert Senturk, MD, Prof, Istanbul University:
Thoracic paravertebral block
Patient controlled analgesia
Video Assisted Thoracoscopic Surgery
Postoperative acute pain
Chronic pain
Additional relevant MeSH terms:
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Pain, Postoperative
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics