Back to resultsThoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS) (VATS)
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Thoracic paravertebral block (TPVB)
Patient Controlled Analgesia (IV PCA)
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Thoracic paravertebral block, Patient controlled analgesia, Video Assisted Thoracoscopic Surgery, Postoperative acute pain, Chronic pain
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
Sites / Locations
- Istanbul University, Department of Anesthesiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patient Controlled Analgesia (IV PCA)
Thoracic Paravertebral Block (TPVB)
Arm Description
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
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)
Outcomes
Primary Outcome Measures
Postoperative chronic pain scores (VAS) at rest and during mobilization
Chronic pain follow-up
Secondary Outcome Measures
Postoperative vital signs
Postoperative early period hemodynamic follow-up
Postoperative acute pain at rest and during coughing/mobilization
Postoperative acute pain score (VAS) follow-up
Postoperative nausea and vomiting (PONV) and antiemetic requirements
Postoperative acute PONV and antiemetic use follow-up
Postoperative morphine consumption
Postoperative IV PCA morphine consumption for Group 1 and IV morphine consumption for Group 2 as rescue analgesic
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
Postoperative first oral intake, flatulence, defecation, mobilization times
Postoperative first oral intake, flatulence, defecation, mobilization times
Postoperative hospital discharge day and time
Postoperative hospital discharge day and time
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02302586
Brief Title
Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)
Acronym
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Thoracic paravertebral block, Patient controlled analgesia, Video Assisted Thoracoscopic Surgery, Postoperative acute pain, Chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Controlled Analgesia (IV PCA)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Thoracic Paravertebral Block (TPVB)
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Thoracic paravertebral block (TPVB)
Other Intervention Name(s)
Bupivacaine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Patient Controlled Analgesia (IV PCA)
Other Intervention Name(s)
Morphine
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative chronic pain scores (VAS) at rest and during mobilization
Description
Chronic pain follow-up
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Postoperative vital signs
Description
Postoperative early period hemodynamic follow-up
Time Frame
0-48 hours
Title
Postoperative acute pain at rest and during coughing/mobilization
Description
Postoperative acute pain score (VAS) follow-up
Time Frame
0-48 hours
Title
Postoperative nausea and vomiting (PONV) and antiemetic requirements
Description
Postoperative acute PONV and antiemetic use follow-up
Time Frame
0-48 hours
Title
Postoperative morphine consumption
Description
Postoperative IV PCA morphine consumption for Group 1 and IV morphine consumption for Group 2 as rescue analgesic
Time Frame
0-48 hours
Title
Time to first analgesic
Description
Postoperative first analgesic IV PCA morphine demand time for Group 1 and first rescue analgesic IV morphine time for Group 2
Time Frame
0-48 hours
Title
Postoperative first oral intake, flatulence, defecation, mobilization times
Description
Postoperative first oral intake, flatulence, defecation, mobilization times
Time Frame
0-48 hours
Title
Postoperative hospital discharge day and time
Description
Postoperative hospital discharge day and time
Time Frame
Participants is being followed for the duration of hospital stay, an expected average of 1 week
Title
Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up
Description
Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up with phone call
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mert N Senturk, Prof
Organizational Affiliation
MD, Prof
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University, Department of Anesthesiology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25091399
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.
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Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)
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