Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine

NCT ID: NCT02814890

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-10-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ropivacaine and dexmedetomidine

Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.

Group Type: EXPERIMENTAL

Video-assisted Pneumonectomy

Intervention Type: PROCEDURE

Video-assisted Pneumonectomy under general anesthesia.

Thoracic paravertebral block

Intervention Type: PROCEDURE

The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side.

Ropivacaine only

Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.

Group Type: ACTIVE_COMPARATOR

Video-assisted Pneumonectomy

Intervention Type: PROCEDURE

Video-assisted Pneumonectomy under general anesthesia.

Thoracic paravertebral block

Intervention Type: PROCEDURE

The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side.

Interventions

Video-assisted Pneumonectomy

Video-assisted Pneumonectomy under general anesthesia.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Thoracic paravertebral nerve block

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jianghui Xu

OTHER

Sponsor Role: lead

Responsible Party

Jianghui Xu

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jun Zhang, MD,PhD

Role: STUDY_CHAIR

Department of Anesthesiology,Huashan Hospital,Fudan University

Locations

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2011QD10

Identifier Type: -

Identifier Source: org_study_id