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Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy

ConditionsDexmedetomidineLidocaineInfusionAdjuvantsGeneral AnesthesiaChronic PainMastectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCairo University

About this trial

This study aims to compare dexmedetomidine and lidocaine infusions as adjuvants to general anesthesia for chronic pain management after mastectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 75 years.

American Society of Anesthesiologists (ASA) physical status II.

Scheduled for mastectomy with axillary dissection (either modified radical mastectomy with or without latissimus dorsi flap or conservative breast surgery) due to breast cancer.

Disqualifiers

Patient refusal.

Known allergy to any of the study drugs.

Those with hepatic or renal insufficiency.

Patients who are running regularly on B blockers.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

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

  • Lidocaine

    Drug

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

  • Isotonic saline

    Drug

    Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Dexmedetomidine groupExperimental treatment 1 intervention
Group B: Lidocaine groupExperimental treatment 1 intervention
Group C: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of the chronic pain

Incidence of the chronic pain will be recorded.

Time frame
6 months postoperatively

Secondary outcomes

1

Time to the 1st rescue analgesia

Time to the 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.

Time frame
48 hours postoperatively
2

Heart rate

Heart rate will be recorded before infusion (Baseline value), 5,10, 15, 30, 45 and 60 minutes and at the end of operation.

Time frame
Till the end of operation (Up to 2 hours)
3

Mean arterial pressure

Mean arterial pressure will be recorded before infusion (Baseline value), 5,10, 15, 30, 45 and 60 minutes and at the end of operation.

Time frame
Till the end of operation (Up to 2 hours)
4

Total morphine consumption

Rescue analgesia of morphine 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses will be given if the visual analogue scale (VAS)\>3.

Time frame
48 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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