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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine and dexmedetomidine | Experimental | Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy. |
|
| Ropivacaine only | Active Comparator | Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video-assisted Pneumonectomy | Procedure | Video-assisted Pneumonectomy under general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | assessed over 48 hours after surgery, self reported pain intensity at 2 days reported |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Hour 48 after surgery |
| Number of Participants With Postoperative Rescue Analgesic Administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, MD,PhD | Department of Anesthesiology,Huashan Hospital,Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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The participants who were converted to thoracotomy because of intraoperative bleeding or pleural adhesions would be wash out.
Sixty-five patients were initially recruited in Auguest, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group RD(Ropivacaine and Dexmedetomidine) | Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy. Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia. Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side. Sixty-five patients were initially recruited. Five patients were excluded from present study, including 3 patients in group RD who were converted to thoracotomy because of intraoperative bleeding or pleural adhesions. |
| FG001 | Group R(Ropivacaine Only) | Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy. Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia. Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side. Sixty-five patients were initially recruited. Five patients were excluded from present study, including 2 patients in group R who were converted to thoracotomy because of intraoperative bleeding or pleural adhesions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group RD(Ropivacaine and Dexmedetomidine) | Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy. Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia. Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side. There were no significant differences between two groups in demographic and operative data(Gender, Age, Weight, Height, ASA（Ⅰ/Ⅱ), FEV1 (% predicted), FEV1/FVC (% predicted), Intraoperative fentanyl, Duration of surgery, Duration of anesthesia). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Measure Analysis Population Description: 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Median | Inter-Quartile Range | units on a scale | assessed over 48 hours after surgery, self reported pain intensity at 2 days reported |
|
Postoperative 48h adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group RD(Ropivacaine and Dexmedetomidine) | Postoperative adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bradycardia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jun Zhang | Huashan Hospital, Fudan University, Shanghai | 0086-021-52887694 | snapzhang@aliyun.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Thoracic paravertebral block | Procedure | The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side. |
|
|
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) |
| Hour 24, Hour 48 after surgery |
| Adverse Events | including nausea, vomiting, hypotension, bradycardia, and respiratory depression | Hour 48 after surgery |
| BG001 | Group R(Ropivacaine Only) | Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy. Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia. Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side. There were no significant differences between two groups in demographic and operative data(Gender, Age, Weight, Height, ASA（Ⅰ/Ⅱ), FEV1 (% predicted), FEV1/FVC (% predicted), Intraoperative fentanyl, Duration of surgery, Duration of anesthesia). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R. | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | Hour 48 after surgery |
|
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | Hour 24, Hour 48 after surgery |
|
|
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| Secondary | Adverse Events | including nausea, vomiting, hypotension, bradycardia, and respiratory depression | Posted | Count of Participants | Participants | Hour 48 after surgery |
|
|
|
|
| 3 |
| 30 |
| 2 |
| 30 |
| EG001 | Group R(Ropivacaine Only) | Postoperative adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated. | 0 | 30 | 3 | 30 |
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 3 point of 5- point Likert scale |
|
| 4 point of 5- point Likert scale |
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| 5 point of 5- point Likert scale |
|