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

NCT ID: NCT03165149

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group (A)

patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % )

Group Type ACTIVE_COMPARATOR

group (A)

Intervention Type 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)

patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) a

Group Type ACTIVE_COMPARATOR

group (B)

Intervention Type 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)

patients will receive 3 mg / kg of Ketamine diluted by 20 ml saline (0.9 %)

Group Type ACTIVE_COMPARATOR

group (c)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Adel El sherif,MD

lecturer of anesthesia, ICU and pain releif

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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South Egypt Cancer Instuite

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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17100205

Identifier Type: -

Identifier Source: org_study_id