Arm 1 Continuous ketamine infusion group for Pain, Postoperative

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Pain, Postoperative+1 More
Continuous ketamine infusion - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether or not ketamine can help chronic pain after mastectomy surgery.

Eligible Conditions
  • Pain, Postoperative

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, 1 and 7 days and 1, 3*, 6, and 12 months after surgery

3 months
BPI pain severity subscale score
Month 12
Pain in the surgical site (chest wall, axilla, and/or arm): BCPQ Score
Month 12
BPI pain severity and pain interference subscales score
Month 12
Incidence of PMS: BPI average pain score
Month 12
Anxiety and depressed mood: Hospital Anxiety and Depression Scale (HADS) Score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

6 Treatment Groups

Arm 1 Continuous ketamine infusion group
1 of 6
Arm 2 Ketamine + Saline group
1 of 6
Arm 1
1 of 6
Arm 2
1 of 6
Arm 3
1 of 6
Arm 3 Placebo group
1 of 6

Active Control

Non-Treatment Group

750 Total Participants · 6 Treatment Groups

Primary Treatment: Arm 1 Continuous ketamine infusion group · Has Placebo Group · Phase 3

Arm 1 Continuous ketamine infusion group
Drug
ActiveComparator Group · 1 Intervention: Continuous ketamine infusion · Intervention Types: Drug
Arm 3
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Arm 3 Placebo group
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Arm 2 Ketamine + Saline group
Drug
ActiveComparator Group · 1 Intervention: Ketamine + Saline · Intervention Types: Drug
Arm 1
Drug
ActiveComparator Group · 1 Intervention: Continuous ketamine infusion · Intervention Types: Drug
Arm 2
Drug
ActiveComparator Group · 1 Intervention: Ketamine + Saline · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 and 7 days and 1, 3*, 6, and 12 months after surgery

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,001 Previous Clinical Trials
41,300,242 Total Patients Enrolled
4 Trials studying Pain, Postoperative
310 Patients Enrolled for Pain, Postoperative
NYU Langone HealthLead Sponsor
1,253 Previous Clinical Trials
742,944 Total Patients Enrolled
9 Trials studying Pain, Postoperative
423 Patients Enrolled for Pain, Postoperative
Lisa Doan, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Pain, Postoperative
31 Patients Enrolled for Pain, Postoperative
Jing Wang, MD, PhDPrincipal InvestigatorNYU Langone Health

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: November 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.