Acute Pain
Conditions
Keywords
postmastectomy pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGKetamine, bupivacine,dexmedetomidine
thoracic epidural catheter insertion at T4-5
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total dose of intravenous morphine consumption in the first 48 hours post operatively | 48 hours postoperative | total dose of intravenous morphine comsumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale | 0, 2,4,6,8,18,36,48 hours | Visual analogue scale will be assessed at rest and on movement (abduction of the ipsi-lateral arm). |
| MAP | 0,30,60,120,150 minutes | mean arterial blood pressure |
| HR | 0,30,60,120,150 minutes | heart rate |
| sedation score | 0, 2,4,6,8,18,36,48 hours | 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 |
Countries
Egypt
Outcome results
None listed