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

Acute Pain Clinical Trial

Official title:

Effect of Adding Dexmedetomidine, Ketamine and Their Combination to Bupivicaine in Thoracic Epidural Analgesia on Post-mastectomy Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063671
• Other study ID #: 110
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2017
• Est. completion date: April 2018

Study information

• Verified date: June 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Ketamine, bupivacine,dexmedetomidine
thoracic epidural catheter insertion at T4-5

Locations

Country	Name	City	State
Egypt	south Egypt cancer institute	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total dose of intravenous morphine consumption in the first 48 hours post operatively	total dose of intravenous morphine comsumption	48 hours postoperative
Secondary	Visual analogue scale	Visual analogue scale will be assessed at rest and on movement (abduction of the ipsi-lateral arm).	0, 2,4,6,8,18,36,48 hours
Secondary	MAP	mean arterial blood pressure	0,30,60,120,150 minutes
Secondary	HR	heart rate	0,30,60,120,150 minutes
Secondary	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	0, 2,4,6,8,18,36,48 hours