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NCT04763434 Clinical Trial

Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study

Dexmedetomidine Clinical Trial

Official title:
Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04763434
Other study ID # GanSu provincial hospital
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date March 20, 2021
Est. completion date August 30, 2021

Study information
Verified date February 2021
Source Gansu Provincial Hospital
Contact wen jun yan, doctor
Phone 17361552758
Email yanwj2008@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The hypothesis is whether perineural dexamethasone and dexmedetomidine prolonged the duration of analgesia as compared with either perineural dexamethasone or perineural dexmedetomidine after TPVB.

Description:

Design: A prospective, randomized, controlled study Setting: Single-center university hospital. Participants: The study included 90 patients undergoing lobectomy under general anesthesia. Interventions: The patients were allocated randomly into the following 3 groups: 20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone (RS group) or 1 µg/kg dexmedetomidine (RM group), or with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group). Ultrasound-guided TPVB was performed at 4 points-T4-5, T5-6, T6-7, and T7-8 of the surgical side; 5 mL of solution were injected at each point. Postoperatively, the PCIA was used as part of multimodal analgesia, and all patients recieve .

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 90
Est. completion date August 30, 2021
Est. primary completion date August 20, 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria: ASA physical status I-II grade Undergoing elective lobectomy under general anesthesia. Participants aged from 16-65 years old. Exclusion Criteria: Refusal for TPVB 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 TPVB Allergy to dexamethasone; dexmedetomidine; ropivacaine Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• dexamethasone; dexmedetomidine; ropivacaine
Ultrasound-guided multilevelTPVB is performed at the end of lobectomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Gansu Provincial Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary the duration of analgesia time from completion of TPVB operation to VAS more than 3 48 hours after surgery
Secondary total sufentanil consumption 48 hours after surgery
Secondary VAS VAS at rest and during coughing are evaluated by a blinded observer postoperatively 1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
Secondary adverse effects 48 hours after surgery
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