Infusion of Dexmedetomidine Versus Lidocaine in Management of Acute Postoperative Pain After Modified Radical Mastectomy

Cairo University (CU)

Status: Completed

Conditions: Postoperative Pain; Acute; Dexmedetomidine; Infusion; Lidocaine; Modified Radical Mastectomy

Treatments: Drug: Lidocaine; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06974656

AP2503-501-100-197

Details and patient eligibility

About

This study aims to compare the effect of intraoperative intravenous infusion of dexmedetomidine and lidocaine in the management of acute postoperative pain after mastectomy.

Full description

Postoperative pain control continues to remain suboptimal, despite multimodal analgesia regimes, minimally invasive surgical techniques, and enhanced recovery programs. Acute postoperative pain hinders patients' functional recovery and represents one of the greatest predictive factors for transition to chronic postsurgical pain.

Among adjuvants, dexmedetomidine, a highly selective α2 adrenoreceptor agonist, and lidocaine, a well-established local anesthetic, seem promising for this purpose.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18 to 65 years.
• American Society of Anesthesiology (ASA) physical status II.
• Body mass index (BMI) 18.5-35 kg/m2.
• Scheduled for modified radical mastectomy.

Exclusion criteria

• Patient's refusal.
• Contraindication to the use of local anesthetics.
• Cardiovascular disease.
• Significant renal/hepatic impairment
• Insulin-dependent diabetes mellitus.
• Central nervous system or psychiatric disease.
• Use of opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks.
• Drug/alcohol abuse.
• Inability to comprehend the pain assessment scale.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Dexmedetomidine group

Experimental group

Description:

Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of n 0.3-0.5 μg/kg/h.

Treatment:

Drug: Dexmedetomidine

Lidocaine group

Experimental group

Description:

Patients will receive a bolus of intravenous lidocaine 1.5mg/kg over 10 min followed by a continuous infusion of lidocaine 1.5-2 mg/kg/h.

Treatment:

Drug: Lidocaine