Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine

Not Applicable

Completed

Conditions: Pain, Postoperative

Interventions: Procedure: Video-assisted Pneumonectomy
Procedure: Thoracic paravertebral block

Registration Number: NCT02814890

Lead Sponsor: Jianghui Xu

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 65

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine only	Video-assisted Pneumonectomy	Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.
Ropivacaine only	Thoracic paravertebral block	Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.
Ropivacaine and dexmedetomidine	Video-assisted Pneumonectomy	Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.
Ropivacaine and dexmedetomidine	Thoracic paravertebral block	Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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