Efficacy of Dexmedetomidine on Postoperative Analgesia

Postoperative Pain Clinical Trial

— EDPARMRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05110339
• Other study ID #: HCAECV01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: Universidad autónoma de Tamaulipas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Mexico	Jose Camilo Muñoz Chaves	Matamoros	Tamaulipas

Sponsors (2)

Lead Sponsor	Collaborator
Universidad autónoma de Tamaulipas	Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	24 hours
Secondary	Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting (%)	24 hours