Clinical trial NCT02814890: Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine
Official title: Thoracic Paravertebral Block Using Ropivacaine With/Without Dexmedetomidine in Video-assisted Pneumonectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Thoracic paravertebral block
Dexmedetomidine
Video-assisted Pneumonectomy
Ropivacaine
Pain, Postoperative
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 65
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative Pain (Pain Scores) Intensity Measure
timeFrame: assessed over 48 hours after surgery, self reported pain intensity at 2 days reported
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Hour 48 after surgery
measure: Number of Participants With Postoperative Rescue Analgesic Administration
timeFrame: Hour 24, Hour 48 after surgery
measure: Adverse Events
timeFrame: Hour 48 after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology,Huashan Hospital,Fudan University
name: Jun Zhang, MD,PhD
role: STUDY_CHAIR
References: