Dexmedetomidine,Ketamine and Their Combination to Bupivicaine on Thoracic Epidural Analgesia

Assiut University20 enrolled

Overview

This study investigate the effect of addition dexmedetomidine, ketamine or their combination to bupivacaine in thoracic epidural analgesia on acute postoperative pain after breast cancer surgery.

Breast cancer is the most common cancer diagnosed in Egyptian women. Many modalities are used in the treatment of breast cancer including chemotherapy, radiotherapy or surgical intervention. Nowadays, surgical intervention is more conservative.Modified radical mastectomy (MRM) is the standard surgical procedure of choice in these patients. MRM is usually performed under general anesthesia, almost always combining intravenous and inhalational agents.The drawback of general anesthesia includes inadequate pain control due to lack of analgesia, high incidence of nausea and vomiting, stress of anesthesia and surgery, and increasing the length of hospital stay.Post mastectomy pain is a pain which occur following breast cancer procedures, particularly those operations that remove tissues in upper outer quadrant of breast and/or axilla. This pain can be severe enough to cause long term disabilities and interfere with sleep, performance of daily activities. Also, it can seriously affect the patient mood, and social functions. Thoracic epidural analgesia (TEA) faces growing interest as adjuvant anesthetic and post-operative analgesic regimen. the use of adjuvant drug with local anesthetic is essential as it prolongs the duration of action, gives better success rate and increases patient satisfaction. Ketamine, an N-methyl-D-aspartate (NMDA) antagonist, not only abolishes peripheral afferent noxious stimulation, but it can also prevent the central sensitization of nociceptors. When added to epidural local anesthetics, ketamine appears to have adjuvant effects. Dexmedetomedine is a selective, α2-adrenoceptor agonist with analgesic potency, sedative properties, and minimal respiratory depression when used as an adjuvant to regional anesthesia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Acute Pain

Interventions

Ketamine, bupivacine,dexmedetomidineDRUG

thoracic epidural catheter insertion at T4-5

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients scheduled for modified radical mastectomy. * ASA Physical status I, II and III. Exclusion Criteria: * Patients' refusal. * Uncooperative patients \& severe psychiatric illness (cannot evaluate their own pain intensity using visual analogue scale (VAS). * Patients with history of drug allergy. * severe renal or liver impairment, unstable ischemic heart disease * Any contraindications to epidural analgesia (coagulopathy, recent -less than 1 week-treatment with thrombolytic or potent antiplatelet drugs as clopidogrel, and local infection).

Locations (1)

south Egypt cancer institute

Asyut, Egypt

Outcomes

Primary Outcomes

total dose of intravenous morphine consumption in the first 48 hours post operatively

total dose of intravenous morphine comsumption

Time frame: 48 hours postoperative

Secondary Outcomes

Visual analogue scale

Visual analogue scale will be assessed at rest and on movement (abduction of the ipsi-lateral arm).

Time frame: 0, 2,4,6,8,18,36,48 hours

MAP

mean arterial blood pressure

Time frame: 0,30,60,120,150 minutes

heart rate

Time frame: 0,30,60,120,150 minutes

sedation score

sedation sore using sedation scale where; 0 = aware - 1 = drowsy - 2 = asleep/easily respond to verbal command - 3 = asleep/difficulty responding to verbal command -4 = asleep/no respond to verbal command

Time frame: 0, 2,4,6,8,18,36,48 hours

Data from ClinicalTrials.gov

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