Efficacy of Dexmedetomidine on Postoperative Analgesia (EDPARMRCT)

Universidad Autónoma de Tamaulipas

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Ropivacaine plus dexmedetomidine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05110339

HCAECV01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Ropivacaine plus Dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine plus dexmedetomidine

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Ropivacaine