Postoperative Pain
Conditions
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.
Interventions
DRUGRopivacaine plus dexmedetomidine
Erector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg.
DRUGRopivacaine
Erector spinae block with ropivacaine at a dose of 0.5%.
Sponsors
Universidad Nacional Autonoma de Mexico
Universidad Autónoma de Tamaulipas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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.
Intervention model description
A prospective randomized double-blinded study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional opioid-type drugs | 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. |
| Postoperative nausea and vomiting | 24 hours | Incidence of postoperative nausea and vomiting (%) |
Countries
Mexico
Outcome results
None listed