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

• ClinicalTrials.gov Identifier: NCT03165149
• Recruitment Status: Completed
• First Posted: May 24, 2017
• Last Update Posted: November 3, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): Fatma Adel El sherif,MD, Assiut University

Tracking Information

• First Submitted Date: May 23, 2017
• First Posted Date: May 24, 2017
• Last Update Posted Date: November 3, 2020
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 23, 2020)

the total amount of morphine consumption [ Time Frame: 48 hours ]

total amount of rescue analgesia

Original Primary Outcome Measures (submitted: May 23, 2017)

pain intensity [ Time Frame: 48 hours ]

pain intensity measured by Visual analogue scale

Current Secondary Outcome Measures (submitted: October 23, 2020)

pain intensity [ Time Frame: 48 hours ]

pain intensity measured by Visual analogue scale

• Original Secondary Outcome Measures (submitted: May 23, 2017): sedation score [ Time Frame: 48 hours ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of a Topical Ketamine on Acute and Chronic Pain, Dose Finding
• Official Title: Effect of a Topical Ketamine on Acute and Chronic Post-mastectomy Pain, Dose Finding - Clinical Study
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Breast Cancer

Intervention

• Drug: 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.
• 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.
• 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.

Study Arms

• Active Comparator: Group (A)
  patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % )
  Intervention: Drug: group (A)
• Active Comparator: Group (B)
  patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) a
  Intervention: Drug: group (B)
• Active Comparator: Group (C)
  patients will receive 3 mg / kg of Ketamine diluted by 20 ml saline (0.9 %)
  Intervention: Drug: group (c)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 23, 2017): 90
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 1, 2020
• Actual Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03165149
• Other Study ID Numbers: 17100205
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Fatma Adel El sherif,MD, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: October 2020