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

Study Overview
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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.

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 .

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

Conditions
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Dexamethasone, Dexmedetomidine, Ropivacaine, Lobectomy

Intervention / Treatment
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* Drug: dexamethasone; dexmedetomidine; ropivacaine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the duration of analgesia | 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 |  | 48 hours after surgery | 
| 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 | 
| adverse effects |  | 48 hours after surgery |