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Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
VATS
PVB using PVC
PCA
Sponsored by
Nguyen Trung Kien
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring paravertebral block,PVC,PCA

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery.

Exclusion Criteria:

  • Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more,, allergy to any of the study drugs, patients having any contraindication to placement of PVB, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease.

Sites / Locations

  • Vietnam Military Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PVB using PVC for PCA in VATS

Arm Description

The VATS was performed.Paravertebral space was identified by loss of resistance technique combined with video-assisted inside thoracic space before chest close.PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA with background rate 3ml/h, bolus dose 2ml was infused through PVC.

Outcomes

Primary Outcome Measures

VAS score at rest and on coughing
Using VAS scale (Atrazennica)

Secondary Outcome Measures

Analgesia effects on respiratory function
Using Spirometry (Chestgraph H1 - 105,Japane) to evaluate respiratory index
Arterial blood gas values
Using Arterial blood gas analysis (STAT Model No.MCP9819-065, Martel Instruments Ltd)
The number dermatome inhibition
Using pin-prick test
Rescue analgesia
When VAS score equal to or more than 4 using fentanyl to manage pain
Patient's satisfaction
Using questionaire with 4 levels :not good,satisfied,good,very good

Full Information

First Posted
July 25, 2017
Last Updated
August 3, 2017
Sponsor
Nguyen Trung Kien
Collaborators
Nguyen Truong Giang, PhD. Associate Prof.
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1. Study Identification

Unique Protocol Identification Number
NCT03242668
Brief Title
Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery
Official Title
Patient Controlled Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nguyen Trung Kien
Collaborators
Nguyen Truong Giang, PhD. Associate Prof.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia.
Detailed Description
The study was carried out on thirty patients who underwent video-assisted thoracic surgery.Paravertebral space was identified by loss of resistance technique under video-assisted inside thoracic space before chest close.Initiated dose of 0.3ml/kg of bupivacaine 0.125%+fentanyl 2 mcg/ml was administered then continued patient-controlled analgesia with background rate 3ml/h, bolus dose 2ml, lockout interval 10 minutes. Postoperative pain was accessed by Visual Analogue Scale at rest and on coughing; monitor the heart rate, blood pressure, respiratory rate, SpO2, arterial blood gas and spirometry in three postoperative consecutive days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
paravertebral block,PVC,PCA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
30 patients, with American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery , were enrolled in this randomised observer blinded prospective clinical study. Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more, allergy to any of the study drugs, patients having any contraindication for paravertebral block, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease were excluded from this study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVB using PVC for PCA in VATS
Arm Type
Experimental
Arm Description
The VATS was performed.Paravertebral space was identified by loss of resistance technique combined with video-assisted inside thoracic space before chest close.PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA with background rate 3ml/h, bolus dose 2ml was infused through PVC.
Intervention Type
Procedure
Intervention Name(s)
VATS
Other Intervention Name(s)
Video-Assisted Thoracic Surgery
Intervention Description
General anesthesia was induced with 2.0 mg/kg of propofol, 2.0 mg/kg of fentanyl, and 1.0 mg kg/1 of rocuronium and maintained with continuous infusion 6-12mg/kg/h of propofol,injected 2.0 mg/kg of fentanyl and 0.15 mg/ kg of rocuronium every 30 minutes . All patients were intubated with a double-lumen endobronchial tube for one-lung ventilation.The VATS (Video-Assisted Thoracic Surgery) was performed.
Intervention Type
Procedure
Intervention Name(s)
PVB using PVC
Other Intervention Name(s)
Paravertebral block using paravertebral catheter
Intervention Description
At the end of the surgery, the upper edge of the spinous process of the thoracic vertebral body was recognized. With an epidural needle (Tuohy 22 G; Braun, Melsungen, Germany), the injection point was punctured 2 cm lateral to the midline. The paravertebral space was entered by advancing the Tuohy needle over the superior border of the transverse process. Once in the right place, the PVC was placed through the needle, checking the tip remained placed when removing the needle. The advance of the needle and the entering of the catheter into the paravertebral space were verified all the time by the surgeon using the camera. The PVC (Paravertebral Catheter ) was inserted at this point preversed at this area.
Intervention Type
Drug
Intervention Name(s)
PCA
Other Intervention Name(s)
Patient controlled analgesia
Intervention Description
PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA (Perfusor space pump,Germany)with background rate 3ml/h, bolus dose 2ml was infused through PVC.
Primary Outcome Measure Information:
Title
VAS score at rest and on coughing
Description
Using VAS scale (Atrazennica)
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Analgesia effects on respiratory function
Description
Using Spirometry (Chestgraph H1 - 105,Japane) to evaluate respiratory index
Time Frame
three postoperative consecutive days
Title
Arterial blood gas values
Description
Using Arterial blood gas analysis (STAT Model No.MCP9819-065, Martel Instruments Ltd)
Time Frame
three postoperative consecutive days
Title
The number dermatome inhibition
Description
Using pin-prick test
Time Frame
three postoperative consecutive days
Title
Rescue analgesia
Description
When VAS score equal to or more than 4 using fentanyl to manage pain
Time Frame
three postoperative consecutive days
Title
Patient's satisfaction
Description
Using questionaire with 4 levels :not good,satisfied,good,very good
Time Frame
three postoperative consecutive days
Other Pre-specified Outcome Measures:
Title
Side effects and complications
Description
Respiratory depression (respiratory rate < 8 breaths/min), ,confusion, sedation, urinary retention, nausea, vomiting, headache and pruritus was evaluated.
Time Frame
three postoperative consecutive days
Title
Heart rate
Description
Using monitoring (Philips)
Time Frame
three postoperative consecutive days
Title
Blood pressure
Description
Using monitoring (Philips)
Time Frame
three postoperative consecutive days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery. Exclusion Criteria: Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more,, allergy to any of the study drugs, patients having any contraindication to placement of PVB, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease.
Facility Information:
Facility Name
Vietnam Military Medical University
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery

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