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

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ClinicalTrials.gov Identifier: NCT03063671
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Shereen Mamdouh, Assiut University

Tracking Information
First Submitted Date  ICMJE February 21, 2017
First Posted Date  ICMJE February 24, 2017
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
total dose of intravenous morphine consumption in the first 48 hours post operatively [ Time Frame: 48 hours postoperative ]
total dose of intravenous morphine comsumption
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
  • Visual analogue scale [ Time Frame: 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 [ Time Frame: 0,30,60,120,150 minutes ]
    mean arterial blood pressure
  • HR [ Time Frame: 0,30,60,120,150 minutes ]
    heart rate
  • sedation score [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine,Ketamine and Their Combination to Bupivicaine on Thoracic Epidural Analgesia
Official Title  ICMJE Effect of Adding Dexmedetomidine, Ketamine and Their Combination to Bupivicaine in Thoracic Epidural Analgesia on Post-mastectomy 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Pain
Intervention  ICMJE Drug: Ketamine, bupivacine,dexmedetomidine
thoracic epidural catheter insertion at T4-5
Study Arms  ICMJE
  • Active Comparator: bupivacine group
    preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% as one shot 15 minutes before general anesthesia postoperative analgesia done by infusion of bupivacaine 0.125% (5ml/hour through thoracic epidural catheter for 12 hours).
    Intervention: Drug: Ketamine, bupivacine,dexmedetomidine
  • Active Comparator: ketamine group
    preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus ketamine in a dose 0.5 mg/kg 15 minutes before general anesthesia postoperative analgesia will be preformed by infusion of mixture of (bupivacaine 0.125% plus ketamine 0.5 mg/ml ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours
    Intervention: Drug: Ketamine, bupivacine,dexmedetomidine
  • Active Comparator: dexmedetomidine group
    preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus dexmedetomidine in a dose 1 ug/kg 15 minutes before general anesthesia Postoperative analgesia will be performed using infusion of mixture of (bupivacaine 0.125% plus dexmedetomedine 2μg/ ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours.
    Intervention: Drug: Ketamine, bupivacine,dexmedetomidine
  • Active Comparator: ketamine-dexmedetomidine group
    preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus both ketamine in a dose 0.3 mg/kg and dexmedetomidine in a dose 0.1 ug/kg 15 minutes before general anesthesia Postoperative analgesia will be performed using infusion of mixture of (bupivacaine 0.125% plus dexmedetomedine 2μg/ ml and and ketamine 0.5 mg/ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours.
    Intervention: Drug: Ketamine, bupivacine,dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 21, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03063671
Other Study ID Numbers  ICMJE 110
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shereen Mamdouh, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP