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Effect of a Topical Ketamine on Acute and Chronic Pain, Dose Finding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165149
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Fatma Adel El sherif,MD, Assiut University

Study Description
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Brief Summary:
The aim of this study is to investigate the effect of addition of different doses of Ketamine locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the probability of developing chronic post-mastectomy pain.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: group (A) Drug: group (B) Drug: group (c) Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Topical Ketamine on Acute and Chronic Post-mastectomy Pain, Dose Finding - Clinical Study
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group (A)
patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % )
 Drug: group (A)
patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % ) and irrigated onto surgical field after hemostats and before skin closure.
Active Comparator: Group (B)
patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) a
 Drug: group (B)
patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) and irrigated onto surgical field after hemostasis and before skin closure.
Active Comparator: Group (C)
patients will receive 3 mg / kg of Ketamine diluted by 20 ml saline (0.9 %)
 Drug: group (c)
patients will receive 3 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) and irrigated onto surgical field after hemostasis and before skin closure.


Outcome Measures
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Primary Outcome Measures :
  1. the total amount of morphine consumption [ Time Frame: 48 hours ]
    total amount of rescue analgesia


Secondary Outcome Measures :
  1. pain intensity [ Time Frame: 48 hours ]
    pain intensity measured by Visual analogue scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- American society of heart association class I-II female patients

  • aged 18-60 years
  • scheduled for modified radical mastectomy with axillary dissection for breast carcinoma

Exclusion Criteria:

  • known allergy to the study drugs
  • significant cardiac-
  • respiratory-
  • renal or hepatic disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165149


Locations
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Egypt
South Egypt Cancer Instuite
Assuit, Egypt, 171516
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Fatma Adel El sherif,MD, lecturer of anesthesia, ICU and pain releif, Assiut University
ClinicalTrials.gov Identifier: NCT03165149    
Other Study ID Numbers: 17100205
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes