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

Assiut University90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Breast Cancer

Interventions

group (A)DRUG

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.

group (B)DRUG

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.

group (c)DRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

South Egypt Cancer Instuite

Asyut, Egypt

Outcomes

Primary Outcomes

the total amount of morphine consumption

total amount of rescue analgesia

Time frame: 48 hours

Secondary Outcomes

pain intensity

pain intensity measured by Visual analogue scale

Time frame: 48 hours

Data from ClinicalTrials.gov

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