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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-20

Study Completion Date

2021-08-30

Brief Summary

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

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Detailed Description

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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 .

Conditions

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Dexamethasone Dexmedetomidine Ropivacaine Lobectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RS group

20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone

Group Type ACTIVE_COMPARATOR

dexamethasone; dexmedetomidine; ropivacaine

Intervention Type DRUG

Ultrasound-guided multilevelTPVB is performed at the end of lobectomy

RM group

20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine

Group Type ACTIVE_COMPARATOR

dexamethasone; dexmedetomidine; ropivacaine

Intervention Type DRUG

Ultrasound-guided multilevelTPVB is performed at the end of lobectomy

RSM group

20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group)

Group Type EXPERIMENTAL

dexamethasone; dexmedetomidine; ropivacaine

Intervention Type DRUG

Ultrasound-guided multilevelTPVB is performed at the end of lobectomy

Interventions

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dexamethasone; dexmedetomidine; ropivacaine

Ultrasound-guided multilevelTPVB is performed at the end of lobectomy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No