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

Phase 4

• Conditions: Dexamethasone; Dexmedetomidine; Ropivacaine; Lobectomy
• Interventions: Drug: dexamethasone; dexmedetomidine; ropivacaine

• Registration Number: NCT04763434
• Lead Sponsor: Gansu Provincial Hospital

Brief 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.

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 Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21
• Study Start: 2021-03-20
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RM group	dexamethasone; dexmedetomidine; ropivacaine	20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine
RSM group	dexamethasone; dexmedetomidine; ropivacaine	20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group)
RS group	dexamethasone; dexmedetomidine; ropivacaine	20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone

Primary Outcome Measures

Name	Time	Method
the duration of analgesia	48 hours after surgery	time from completion of TPVB operation to VAS more than 3

Secondary Outcome Measures

Name	Time	Method
total sufentanil consumption	48 hours after surgery
VAS	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
adverse effects	48 hours after surgery