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Efficacy of Dexmedetomidine on Postoperative Analgesia

NCT ID: NCT05110339

Last Updated: 2021-11-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-09-30

Brief Summary

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This prospective, randomized, double-blind study is designed to evaluate the postoperative analgesic efficacy of dexmedetomidine as an adjunct to ropivacaine in erector spinae block in patients undergoing radical mastectomy. The investigators hypothesis is that the administration of ropivacaine 0.5% associated with dexmedetomidine in the blockade via the plane in the erector spinae is less effective in controlling acute postoperative pain in radical mastectomy than the administration of ropivacaine 0.5% without dexmedetomidine.

Detailed Description

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Patients undergoing radical mastectomy are randomly assigned to receive, in addition to standard general anesthesia, a block of the erector spinae plane with ropivacaine at a dose of 0.5% for the control group (n = 13) and ropivacaine at a dose of 0.5% more dexmedetomidine at 0.3 mcg kg (n = 15) for the intervention group. General anesthesia was induced using anxiolysis with midazolam at 30 mcg / kg corrected weight, as induction, propofol at a dose of 1.5 - 2 mg kg, opioid analgesia with fentanyl at a dose of 3 mcg / kg weight corrected with 30% according to ideal weight initial bolus dose, and dose as required, neuromuscular relaxation with cisatracurium at a dose of 0.1 mg / kg.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective randomized double-blinded study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The outcome assessor did not know the allocation of the participants. The patient is not informed of the medication used in the erector spinae block.

Study Groups

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Ropivacaine plus Dexmedetomidine

In addition to standard general anesthesia, patients receive erector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg corrected in a volume of 20 ml at the level of thoracic vertebra number 4, guided with ultrasound and under sterile technique, the date and time of application are recorded on the data collection sheet.

Group Type EXPERIMENTAL

Ropivacaine plus dexmedetomidine

Intervention Type DRUG

Erector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg.

Control group

In addition to standard general anesthesia, patients receive erector spinae block with ropivacaine at a dose of 0.5% in a volume of 20 ml at the level of thoracic vertebra number 4, guided with ultrasound and under sterile technique, the date and time of application are recorded on the data collection sheet.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Erector spinae block with ropivacaine at a dose of 0.5%.

Interventions

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Ropivacaine plus dexmedetomidine

Erector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg.

Intervention Type DRUG

Ropivacaine

Erector spinae block with ropivacaine at a dose of 0.5%.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing radical mastectomy for pathology "breast cancer"
* Patient undergoing anesthetic technique due to erector spinae plane block
* Informed consent to perform the anesthesia technique.
* Karnofsky\> 80 points

Exclusion Criteria

* Emergency surgery
* Patient with mental pathology that prevents pain assessment.
* Rejection of anesthetic technique.
* Patient with allergy to local anesthetics
* Patient with local infection of the puncture site for application of the erector spinae block
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role collaborator

Universidad Autónoma de Tamaulipas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jose Camilo Muñoz Chaves

Matamoros, Tamaulipas, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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HCAECV01

Identifier Type: -

Identifier Source: org_study_id