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Completed

NCT Number: NCT05110339

Efficacy of Dexmedetomidine on Postoperative Analgesia

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jose Camilo Muñoz Chaves

Matamoros, Tamaulipas, 87000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine plus dexmedetomidine

Drug

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

Ropivacaine

Drug

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

Primary outcomes

  1. Postoperative Pain score

    Time frame: 0 hours

    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"

  2. Postoperative Pain score

    Time frame: 6 hours

    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"

  3. Postoperative Pain score

    Time frame: 12 hours

    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"

  4. Postoperative Pain score

    Time frame: 24 hours

    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 outcomes

  1. Additional opioid-type drugs

    Time frame: 24 hours

    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.

  2. Postoperative nausea and vomiting

    Time frame: 24 hours

    Incidence of postoperative nausea and vomiting (%)

Sponsors and collaborators

Lead sponsor

Universidad Autónoma de Tamaulipas

Other

Collaborators

  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

Efficacy of Dexmedetomidine on Postoperative Analgesia After Radical Mastectomy: Randomized Controlled Trial

Acronym: EDPARMRCT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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