NCT05110339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

October 12, 2021

Last Update Submit

October 25, 2021

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (4)

  • 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"

    0 hours

  • 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"

    6 hours

  • 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"

    12 hours

  • 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"

    24 hours

Secondary Outcomes (2)

  • Additional opioid-type drugs

    24 hours

  • Postoperative nausea and vomiting

    24 hours

Study Arms (2)

Ropivacaine plus Dexmedetomidine

EXPERIMENTAL

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.

Drug: Ropivacaine plus dexmedetomidine

Control group

ACTIVE COMPARATOR

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.

Drug: Ropivacaine

Interventions

Ropivacaine plus dexmedetomidineDRUG

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

Ropivacaine plus Dexmedetomidine
RopivacaineDRUG

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

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jose Camilo Muñoz Chaves

Matamoros, Tamaulipas, 87000, Mexico

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineDexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective randomized double-blinded study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

November 5, 2021

Study Start

November 1, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

November 5, 2021

Record last verified: 2021-10

Locations

ME(1)