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

Ketamine

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.

Intervention / Treatment

  • 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.

Condition or Disease

  • Breast Cancer

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 90 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jun 01, 2017 ACTUAL
    Primary Completion: Aug 01, 2019 ACTUAL
    Completion Date: Mar 01, 2020 ACTUAL
    Study First Posted: May 24, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 02, 2020

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Asyut, Egypt

    Participant Groups

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

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

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

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • total amount of rescue analgesia

    Secondary Outcomes

    • pain intensity measured by Visual analogue scale

    More Details

    NCT Number: NCT03165149
    Other IDs: 17100205
    Study URL: https://clinicaltrials.gov/study/NCT03165149
    Last updated: Sep 29, 2023