Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Video-assisted Pneumonectomy
Thoracic paravertebral block
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Thoracic paravertebral block, Dexmedetomidine, Video-assisted Pneumonectomy, Ropivacaine, Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- ASA physical status I-II grade
- Undergoing elective video-assisted pneumonectomy under general anesthesia.
- Participants aged from 30-70 years old.
Exclusion Criteria:
- Refusal for paravertebral block
- Inability to obtain informed consent
- Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2
- Pregnancy
- Infections at the site of injection for the paravertebral block
- Allergy to local anesthetics or alpha-2 adrenergic agonists
- Heart block or bradycardia (heart rate < 60 beat per minute)
- Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases
Sites / Locations
- Huashan Hospital Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ropivacaine and dexmedetomidine
Ropivacaine only
Arm Description
Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.
Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.
Outcomes
Primary Outcome Measures
Postoperative Pain (Pain Scores) Intensity Measure
Pain Numerical Rating Scales (NRS) at rest(0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
Secondary Outcome Measures
Patient Satisfaction
using a 5-point Likert scale (5-point: completely satisfied, 4-point: quite satisfied, 3-point: slightly dissatisfied, 2-point: dissatisfied, 1-point: very dissatisfied)
Number of Participants With Postoperative Rescue Analgesic Administration
a rescue analgesic morphine 5mg will be administered for any pain score ≥4 (0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
Adverse Events
including nausea, vomiting, hypotension, bradycardia, and respiratory depression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02814890
Brief Title
Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine
Official Title
Thoracic Paravertebral Block Using Ropivacaine With/Without Dexmedetomidine in Video-assisted Pneumonectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jianghui Xu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral block is performed at the end of video-assisted pneumonectomy.
Detailed Description
The investigators aim to recruit 60 patients undergoing video-assisted pneumonectomy. All patients ASA physical status I-II grade, aged within 20-70 years, are randomly allocated into two groups: 75mg/20ml ropivacaine only group (Group R, n=30) and 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine (Group RD, n=30). At the end of surgery, the investigators perform four points thoracic paravertebral block guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side where 5ml solution is injected to each point. The characteristics of patients are analyzed to confirm whether they are comparable in both groups. Pain was assessed according to a numerical rating scale (NRS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded in post anesthesia care unit(PACU), and1, 2,4, 8, 12, 24, 36 and 48 hours after surgery. The study endpoints are evaluated by an anesthesiologist who does not know the group allocation. The postoperative rescue analgesic administration, adverse outcomes and patient satisfaction are also recorded.
All data were processed in SPSS 18.0 (SPSS Inc., Chicago, IL USA). Normality was tested by the Kolmogorov-Smirnov analysis. Comparisons of continuous outcomes among groups were examined using Kruskal-Wallis test. Chi-square analysis or Fisher's exact test was used to assess categorical outcomes between groups. A P-value<0.05 was considered statistically significant.
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, Dexmedetomidine, Video-assisted Pneumonectomy, Ropivacaine, Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine and dexmedetomidine
Arm Type
Experimental
Arm Description
Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.
Arm Title
Ropivacaine only
Arm Type
Active Comparator
Arm Description
Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.
Intervention Type
Procedure
Intervention Name(s)
Video-assisted Pneumonectomy
Intervention Description
Video-assisted Pneumonectomy under general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Thoracic paravertebral block
Other Intervention Name(s)
Thoracic paravertebral nerve block
Intervention Description
The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side.
Primary Outcome Measure Information:
Title
Postoperative Pain (Pain Scores) Intensity Measure
Description
Pain Numerical Rating Scales (NRS) at rest(0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
Time Frame
assessed over 48 hours after surgery, self reported pain intensity at 2 days reported
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
using a 5-point Likert scale (5-point: completely satisfied, 4-point: quite satisfied, 3-point: slightly dissatisfied, 2-point: dissatisfied, 1-point: very dissatisfied)
Time Frame
Hour 48 after surgery
Title
Number of Participants With Postoperative Rescue Analgesic Administration
Description
a rescue analgesic morphine 5mg will be administered for any pain score ≥4 (0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
Time Frame
Hour 24, Hour 48 after surgery
Title
Adverse Events
Description
including nausea, vomiting, hypotension, bradycardia, and respiratory depression
Time Frame
Hour 48 after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA physical status I-II grade
Undergoing elective video-assisted pneumonectomy under general anesthesia.
Participants aged from 30-70 years old.
Exclusion Criteria:
Refusal for paravertebral block
Inability to obtain informed consent
Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2
Pregnancy
Infections at the site of injection for the paravertebral block
Allergy to local anesthetics or alpha-2 adrenergic agonists
Heart block or bradycardia (heart rate < 60 beat per minute)
Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, MD,PhD
Organizational Affiliation
Department of Anesthesiology,Huashan Hospital,Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine
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