KALPAS

Currently Recruiting: Participants

Study Drug/Intervention: Ketamine

Study Timeline: This study is expected to conclude in August 2026.

Visit the Study Website

ClinicalTrials.gov ID: NCT05037123

Study Objectives

To determine the effectiveness of continuous ketamine infusion and single-dose ketamine to reduce pain at the surgical site at 3 months after surgery as assessed by the Brief Pain Inventory (BPI) pain severity subscale.

To determine the effect of continuous ketamine infusion and single-dose ketamine on postoperative pain, function, and mood.

Inclusion Criteria

To be eligible to participate in this study, an individual must meet all of the following criteria:

Woman 18 years of age or older

Undergoing elective breast surgery for oncologic indication such as: unilateral or bilateral mastectomy

• Prophylactic mastectomy
• +/- lymph node dissection,
• +/- Immediate or delayed reconstruction

No distant metastases

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

History of cognitive impairment or clinical signs of altered mental status (AMS) that may interfere with adherence to study procedures and/or participant safety. Clinical signs of AMS may include but are not limited to: confusion, amnesia, disorientation, fluctuating levels of alertness etc.

• Past ketamine or phencyclidine misuse or abuse
• Schizophrenia or history of psychosis
• History of post-traumatic stress disorder
• Known sensitivity or allergy to ketamine
• Liver or renal insufficiency

History of uncontrolled hypertension, chest pain, cardiac arrhythmia, stroke, head trauma, intracranial mass or hemorrhage, glaucoma, porphyria, uncontrolled thyroid disease, or other contraindication to ketamine

• Lamotrigine, alfentanil, physostigmine, or 4-aminopyridine use
• Currently Pregnant
• Body mass index (BMI) equal to or greater than 41
• Non-English or non-Spanish speaker
• Currently participating in another pain interventional trial
• Unwilling to comply with all study procedures and be available for the duration of the study
• Patient is American Society of Anesthesiologists (ASA) physical status 4, 5, or 6
• Patient has started or undergone hormone therapy for gender transition into male.
• Patient scheduled for any bilateral (or greater) flap reconstruction

National Cancer Institute (NCI)

• PI: Jing Wang
• PL: Princess Abbott