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

Sponsor

Gansu Provincial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04763434

Collaborator

(none)

Enrollment

Arms

5.4

Anticipated Duration (Months)

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Mar 20, 2021

Anticipated Primary Completion Date :

Aug 20, 2021

Anticipated Study Completion Date :

Aug 30, 2021

Arms and Interventions

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

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

Primary Outcome Measures

the duration of analgesia [48 hours after surgery]
time from completion of TPVB operation to VAS more than 3

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Gansu Provincial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

dong zhang, dong zhang, Gansu Provincial Hospital

ClinicalTrials.gov Identifier:

NCT04763434

Other Study ID Numbers:

GanSu provincial hospital

First Posted:

Feb 21, 2021

Last Update Posted:

Feb 21, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Dexamethasone

Dexmedetomidine

Ropivacaine

Study Results

No Results Posted as of Feb 21, 2021