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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03165149
Enrollment
90
Registered
2017-05-24
Start date
2017-06-01
Completion date
2020-03-01
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

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.

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.

DRUGgroup (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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the total amount of morphine consumption48 hourstotal amount of rescue analgesia

Secondary

MeasureTime frameDescription
pain intensity48 hourspain intensity measured by Visual analogue scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026