Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine

Thoracic Paravertebral Block Using Ropivacaine With/Without Dexmedetomidine in Video-assisted Pneumonectomy

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Video-assisted Pneumonectomy; Procedure: Thoracic paravertebral block

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ropivacaine and dexmedetomidine; Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.	Procedure: Video-assisted Pneumonectomy; Video-assisted Pneumonectomy under general anesthesia.; Procedure: Thoracic paravertebral block; The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side.; Other Names: Thoracic paravertebral nerve block
ACTIVE_COMPARATOR: Ropivacaine only; Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.	Procedure: Video-assisted Pneumonectomy; Video-assisted Pneumonectomy under general anesthesia.; Procedure: Thoracic paravertebral block; The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side.; Other Names: Thoracic paravertebral nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jianghui Xu
• Investigators: Study Chair: Jun Zhang, MD,PhD, Department of Anesthesiology,Huashan Hospital,Fudan University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (ESTIMATE): June 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Thoracic paravertebral block; Ropivacaine; Pain, Postoperative; Video-assisted Pneumonectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2011QD10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO