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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

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ClinicalTrials.gov Identifier: NCT04763434
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
dong zhang, Gansu Provincial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dexamethasone Dexmedetomidine Ropivacaine Lobectomy Drug: dexamethasone; dexmedetomidine; ropivacaine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study
Estimated Study Start Date : March 20, 2021
Estimated Primary Completion Date : August 20, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. the duration of analgesia [ Time Frame: 48 hours after surgery ]
    time from completion of TPVB operation to VAS more than 3


Secondary Outcome Measures :
  1. total sufentanil consumption [ Time Frame: 48 hours after surgery ]
  2. 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

  3. adverse effects [ Time Frame: 48 hours after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763434


Contacts
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Contact: wen jun yan, doctor 17361552758 yanwj2008@hotmail.com

Sponsors and Collaborators
Gansu Provincial Hospital
More Information
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Responsible Party: dong zhang, Gansu Provincial Hospital
ClinicalTrials.gov Identifier: NCT04763434    
Other Study ID Numbers: GanSu provincial hospital
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Additional relevant MeSH terms:
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Dexamethasone
Dexmedetomidine
Ropivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Hypnotics and Sedatives
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics