Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy

NCT04831736 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21-00072
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy. The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.

Conditions

Postoperative Pain

Keywords

Mastectomy

Outcome Measures

Primary Outcomes (2)

• Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score

  BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.

  24 Hours Post-Op (Day 2)

• Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score

  BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.

  48 Hours Post-Op (Day 3)

Secondary Outcomes (23)

• Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score

  Baseline (Day 0)

• Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score

  Day 7 Post-Op (Day 8)

• Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score

  Baseline (Day 0)

• Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score

  Day 1 Post-Op (Day 2)

• Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score

  Day 2 Post-Op (Day 3)

Study Arms (2)

Treatment

EXPERIMENTAL

Drug: Ketamine

Control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ketamine DRUG

Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0.

Treatment

Placebo DRUG

Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women, aged 18 to 80 years old, who will undergo mastectomy.
• Willing to comply with all study procedures and be available for the duration of the study.
• Will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction
• No distant metastases.
• Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
• Subject is medically stable.

You may not qualify if:

• Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety.
• Past ketamine or phencyclidine misuse or abuse.
• Schizophrenia or history of psychosis.
• Known sensitivity or allergy to ketamine.
• Liver or renal insufficiency.
• History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated
• Pregnancy or nursing women
• BMI\>35.
• Currently participating in another pain interventional trial.
• Unwillingness to give informed consent.
• Non-English speaking patients as QoR-15 and BCPQ have not been validated in all other languages

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Lisa Doan, MD
• Organization: NYU Langone Health

Lisa.Doan@nyulangone.org

212-201-1004

Study Officials

• Lisa Doan, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: April 26, 2021
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: May 16, 2023
• Results First Posted: May 16, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to lisa.doan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)