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OpenTrials
Completed

NCT Number: NCT03165149

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

South Egypt Cancer Instuite

Asyut, 171516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. the total amount of morphine consumption

    Time frame: 48 hours

    total amount of rescue analgesia

Secondary outcomes

  1. pain intensity

    Time frame: 48 hours

    pain intensity measured by Visual analogue scale

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 24, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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