Acute Pain Clinical Trial
Official title:
Effect of Adding Dexmedetomidine, Ketamine and Their Combination to Bupivicaine in Thoracic Epidural Analgesia on Post-mastectomy Pain
NCT number | NCT03063671 |
Other study ID # | 110 |
Secondary ID | |
Status | Completed |
Phase | Phase 2/Phase 3 |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | April 2018 |
Verified date | June 2019 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Egypt | south Egypt cancer institute | Assuit |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
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 |
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