search
Back to results

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
Jianghui Xu
About
Eligibility
Locations
Arms
Outcomes
Full info

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

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 21, 2016
Last Updated
August 5, 2020
Sponsor
Jianghui Xu
search

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

Learn more about this trial

Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine

We'll reach out to this number within 24 hrs