NCT03165149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

May 23, 2017

Last Update Submit

November 2, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • the total amount of morphine consumption

    total amount of rescue analgesia

    48 hours

Secondary Outcomes (1)

  • pain intensity

    48 hours

Study Arms (3)

Group (A)

ACTIVE COMPARATOR

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

Drug: group (A)

Group (B)

ACTIVE COMPARATOR

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

Drug: group (B)

Group (C)

ACTIVE COMPARATOR

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

Drug: group (c)

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 (A)
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 (B)
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.

Group (C)

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • known allergy to the study drugs
  • significant cardiac-
  • respiratory-
  • renal or hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Instuite

Asyut, 171516, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia, ICU and pain releif

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 24, 2017

Study Start

June 1, 2017

Primary Completion

August 1, 2019

Study Completion

March 1, 2020

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)