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Efficacy of Dexmedetomidine on Postoperative Analgesia (EDPARMRCT)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Ropivacaine plus dexmedetomidine
Ropivacaine
Sponsored by
Universidad Autónoma de Tamaulipas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Jose Camilo Muñoz Chaves

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ropivacaine plus Dexmedetomidine

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Postoperative Pain score
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Postoperative Pain score
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Postoperative Pain score
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Postoperative Pain score
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"

Secondary Outcome Measures

Additional opioid-type drugs
The presence of additional opioid analgesic requirements will be evaluated. All patients will be prescribed intravenous analgesia on a strict schedule as follows: ketorolac 30mg in intravenous infusion every 8 hours. If the follow-up assessment of postoperative pain is greater than or equal to 4 in the VAS, additional medication is indicated, which is considered as analgesic rescue and which consists of buprenorphine at a dose of 2 mcg kg corrected with 30% according to ideal weight intravenously in both groups, with a dose no greater than 6 mcg / kg / day.
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)

Full Information

First Posted
October 12, 2021
Last Updated
October 25, 2021
Sponsor
Universidad Autónoma de Tamaulipas
Collaborators
Universidad Nacional Autonoma de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT05110339
Brief Title
Efficacy of Dexmedetomidine on Postoperative Analgesia
Acronym
EDPARMRCT
Official Title
Efficacy of Dexmedetomidine on Postoperative Analgesia After Radical Mastectomy: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Autónoma de Tamaulipas
Collaborators
Universidad Nacional Autonoma de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective randomized double-blinded study
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine plus Dexmedetomidine
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine plus dexmedetomidine
Intervention Description
Erector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Erector spinae block with ropivacaine at a dose of 0.5%.
Primary Outcome Measure Information:
Title
Postoperative Pain score
Description
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Time Frame
0 hours
Title
Postoperative Pain score
Description
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Time Frame
6 hours
Title
Postoperative Pain score
Description
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Time Frame
12 hours
Title
Postoperative Pain score
Description
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Additional opioid-type drugs
Description
The presence of additional opioid analgesic requirements will be evaluated. All patients will be prescribed intravenous analgesia on a strict schedule as follows: ketorolac 30mg in intravenous infusion every 8 hours. If the follow-up assessment of postoperative pain is greater than or equal to 4 in the VAS, additional medication is indicated, which is considered as analgesic rescue and which consists of buprenorphine at a dose of 2 mcg kg corrected with 30% according to ideal weight intravenously in both groups, with a dose no greater than 6 mcg / kg / day.
Time Frame
24 hours
Title
Postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting (%)
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Jose Camilo Muñoz Chaves
City
Matamoros
State/Province
Tamaulipas
ZIP/Postal Code
87000
Country
Mexico

12. IPD Sharing Statement

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Efficacy of Dexmedetomidine on Postoperative Analgesia

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