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

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine, bupivacine,dexmedetomidine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pain focused on measuring postmastectomy pain

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • south Egypt cancer institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

bupivacine group

ketamine group

dexmedetomidine group

ketamine-dexmedetomidine group

Arm Description

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).

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

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.

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.

Outcomes

Primary Outcome Measures

total dose of intravenous morphine consumption in the first 48 hours post operatively
total dose of intravenous morphine comsumption

Secondary Outcome Measures

Visual analogue scale
Visual analogue scale will be assessed at rest and on movement (abduction of the ipsi-lateral arm).
MAP
mean arterial blood pressure
HR
heart rate
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

Full Information

First Posted
February 21, 2017
Last Updated
June 27, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03063671
Brief Title
Dexmedetomidine,Ketamine and Their Combination to Bupivicaine on Thoracic Epidural Analgesia
Official Title
Effect of Adding Dexmedetomidine, Ketamine and Their Combination to Bupivicaine in Thoracic Epidural Analgesia on Post-mastectomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
postmastectomy pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bupivacine group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
ketamine group
Arm Type
Active Comparator
Arm Description
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
Arm Title
dexmedetomidine group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ketamine-dexmedetomidine group
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine, bupivacine,dexmedetomidine
Intervention Description
thoracic epidural catheter insertion at T4-5
Primary Outcome Measure Information:
Title
total dose of intravenous morphine consumption in the first 48 hours post operatively
Description
total dose of intravenous morphine comsumption
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
Visual analogue scale will be assessed at rest and on movement (abduction of the ipsi-lateral arm).
Time Frame
0, 2,4,6,8,18,36,48 hours
Title
MAP
Description
mean arterial blood pressure
Time Frame
0,30,60,120,150 minutes
Title
HR
Description
heart rate
Time Frame
0,30,60,120,150 minutes
Title
sedation score
Description
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
Time Frame
0, 2,4,6,8,18,36,48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
south Egypt cancer institute
City
Assuit
Country
Egypt

12. IPD Sharing Statement

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

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