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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02462681
Date of registration: 30/05/2015
Prospective Registration: No
Primary sponsor: Assiut University
Public title: Ketamine as Adjunctive Analgesic With Bupivacaine in Paravertebral Analgesia for Breast Cancer Surgery
Scientific title: Ketamine as Adjunctive Analgesic With Bupivacaine in Paravertebral Analgesia for Breast Cancer Surgery
Date of first enrolment: May 2015
Target sample size: 90
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02462681
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 1/Phase 2
Countries of recruitment
Egypt
Contacts
Name:     Sahar A. Mohamed, MD
Address: 
Telephone:
Email:
Affiliation:  Lecturer of anesthesia, ICU and pain management- South Egypt Cancer Institute- Assuit University
Key inclusion & exclusion criteria

Inclusion Criteria:

- all patients scheduled for elective modified radical mastectomy with axillary
dissection will be enrolled in the study

Exclusion Criteria:

- patients with a known allergy to the study drugs

- patients with bleeding diathesis

- patients with infection at the site of injection

- patients with central neuropathy

- patients with liver impairment

- patients with renal impairment

- drugs or alcohol abusers

- patients with psychiatric illnesses



Age minimum: 25 Years
Age maximum: 70 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Acute Pain
Chronic Pain
Intervention(s)
Drug: paravertebral block
Primary Outcome(s)
changes in pain intensity score from baseline [Time Frame: at 2,4,6,12,24,36and 48 hour postoperatively]
Secondary Outcome(s)
chronic neuropathic pain [Time Frame: 1st,2nd and 3rd postoperative months]
side effect [Time Frame: 2,4,6,12,24,36and 48 hour postoperatively.]
Secondary ID(s)
211
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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