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

Effect of a Topical Ketamine on Acute and Chronic Post-mastectomy Pain, Dose Finding - Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: group (A); Drug: group (B); Drug: group (c)

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt, 171516
    • South Egypt Cancer Instuite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the total amount of morphine consumption	total amount of rescue analgesia	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	pain intensity measured by Visual analogue scale	48 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17100205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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