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

February 17, 2021 updated by: dong zhang, Gansu Provincial Hospital
The hypothesis is whether perineural dexamethasone and dexmedetomidine prolonged the duration of analgesia as compared with either perineural dexamethasone or perineural dexmedetomidine after TPVB.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 .

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RS group
20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone
Drug: dexamethasone; dexmedetomidine; ropivacaine
Ultrasound-guided multilevelTPVB is performed at the end of lobectomy
Active Comparator: RM group
20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine
Drug: dexamethasone; dexmedetomidine; ropivacaine
Ultrasound-guided multilevelTPVB is performed at the end of lobectomy
Experimental: RSM group
20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group)
Drug: dexamethasone; dexmedetomidine; ropivacaine
Ultrasound-guided multilevelTPVB is performed at the end of lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the duration of analgesia
Time Frame: 48 hours after surgery
time from completion of TPVB operation to VAS more than 3
48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total sufentanil consumption
Time Frame: 48 hours after surgery
48 hours after surgery
VAS
Time Frame: 1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
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
adverse effects
Time Frame: 48 hours after surgery
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gansu Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2021

Primary Completion (Anticipated)

August 20, 2021

Study Completion (Anticipated)

August 30, 2021

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GanSu provincial hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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