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NCT Number: NCT02814890

Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video-assisted Pneumonectomy

Procedure

Video-assisted Pneumonectomy under general anesthesia.

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.

Other names: Thoracic paravertebral nerve block

Primary outcomes

  1. Postoperative Pain (Pain Scores) Intensity Measure

    Time frame: 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 outcomes

  1. Patient Satisfaction

    Time frame: 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)

  2. Number of Participants With Postoperative Rescue Analgesic Administration

    Time frame: 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)

  3. Adverse Events

    Time frame: Hour 48 after surgery

    including nausea, vomiting, hypotension, bradycardia, and respiratory depression

Sponsors and collaborators

Lead sponsor

Jianghui Xu

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 28, 2016
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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