Pain, Postoperative
Conditions
Keywords
Thoracic paravertebral block, Dexmedetomidine, Video-assisted Pneumonectomy, Ropivacaine, Pain, Postoperative
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.
Interventions
PROCEDUREVideo-assisted Pneumonectomy
Video-assisted Pneumonectomy under general anesthesia.
PROCEDUREThoracic paravertebral block
The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side.
Sponsors
Jianghui Xu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain (Pain Scores) Intensity Measure | assessed over 48 hours after surgery, self reported pain intensity at 2 days reported | Pain Numerical Rating Scales （NRS) at rest（0: no pain--means the minimum value; 10: worst possible pain--means the maximum value) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Hour 48 after surgery | 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 | Hour 24, Hour 48 after surgery | 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 | Hour 48 after surgery | including nausea, vomiting, hypotension, bradycardia, and respiratory depression |
Countries
China
Participant flow
Recruitment details
Sixty-five patients were initially recruited in Auguest, 2016.
Pre-assignment details
The participants who were converted to thoracotomy because of intraoperative bleeding or pleural adhesions would be wash out.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 33 |
| 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). | 32 |
| Total | 65 |
Baseline characteristics
| Characteristic | Group RD(Ropivacaine and Dexmedetomidine) | Group R(Ropivacaine Only) | Total |
|---|---|---|---|
| Age, Continuous analyzed number of participants | 59.2 years STANDARD_DEVIATION 9.7 | 59.5 years STANDARD_DEVIATION 9.7 | 59.3 years STANDARD_DEVIATION 9.6 |
| Age, Continuous recruited number of participants | 59.2 years STANDARD_DEVIATION 9.6 | 59.7 years STANDARD_DEVIATION 9.4 | 59.6 years STANDARD_DEVIATION 9.3 |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 30 | 3 / 30 |
| serious Total, serious adverse events | 3 / 30 | 0 / 30 |
Outcome results
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)
Time frame: assessed over 48 hours after surgery, self reported pain intensity at 2 days reported
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group RD(Ropivacaine and Dexmedetomidine) | Postoperative Pain (Pain Scores) Intensity Measure | 1 units on a scale |
| Group R(Ropivacaine Only) | Postoperative Pain (Pain Scores) Intensity Measure | 3 units on a scale |
Comparison: Sample size: Based on our previous data, pain score at rest 48 hours postoperatively when using ropivacaine only was of 2.8 with a standard deviation of 1.4. Assuming a decrease of pain score by 1.1 being clinically significant, twenty six patents in each group would be required for a study power of 80% (α=0.05,β=0.2). Considering possible dropouts, we aimed at recruiting 30 patients in each group with a total of 60 patients.p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Adverse Events
including nausea, vomiting, hypotension, bradycardia, and respiratory depression
Time frame: Hour 48 after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group RD(Ropivacaine and Dexmedetomidine) | Adverse Events | 5 Participants |
| Group R(Ropivacaine Only) | Adverse Events | 3 Participants |
p-value: >0.05Fisher Exact
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)
Time frame: Hour 24, Hour 48 after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group RD(Ropivacaine and Dexmedetomidine) | Number of Participants With Postoperative Rescue Analgesic Administration | 1 Participants |
| Group R(Ropivacaine Only) | Number of Participants With Postoperative Rescue Analgesic Administration | 1 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)
Time frame: Hour 48 after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group RD(Ropivacaine and Dexmedetomidine) | Patient Satisfaction | 2 point of 5- point Likert scale | 0 Participants |
| Group RD(Ropivacaine and Dexmedetomidine) | Patient Satisfaction | 4 point of 5- point Likert scale | 9 Participants |
| Group RD(Ropivacaine and Dexmedetomidine) | Patient Satisfaction | 3 point of 5- point Likert scale | 1 Participants |
| Group RD(Ropivacaine and Dexmedetomidine) | Patient Satisfaction | 5 point of 5- point Likert scale | 20 Participants |
| Group RD(Ropivacaine and Dexmedetomidine) | Patient Satisfaction | 1 point of 5- point Likert scale | 0 Participants |
| Group R(Ropivacaine Only) | Patient Satisfaction | 5 point of 5- point Likert scale | 6 Participants |
| Group R(Ropivacaine Only) | Patient Satisfaction | 1 point of 5- point Likert scale | 0 Participants |
| Group R(Ropivacaine Only) | Patient Satisfaction | 2 point of 5- point Likert scale | 0 Participants |
| Group R(Ropivacaine Only) | Patient Satisfaction | 3 point of 5- point Likert scale | 7 Participants |
| Group R(Ropivacaine Only) | Patient Satisfaction | 4 point of 5- point Likert scale | 17 Participants |