The Ketamine for Acute Postoperative Analgesia (KAPA) Trial

NCT04646694 | Completed Phase 3

• 1 other identifier: 20-5064
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain remains an important challenge for both patients and clinicians. Despite advances in pain management techniques, many patients continue to describe their pain as moderate to severe immediately after surgery. Poor postoperative pain control is associated with increased morbidity, functional impairment, and higher health care costs. While opioids currently represent the mainstay of treating surgical pain, their use is associated with significant side effects including respiratory depression, delayed recovery of bowel function as well as the potential for long-term use. Therefore, there is an urgent need to find new pain relievers with a safer side effect profiles. One such drug that has been receiving increasing attention is ketamine. Previous studies have focused on using intravenous ketamine postoperatively which requires a monitored setting but have ignored the oral form. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. Therefore, Investigators propose to conduct the Ketamine for Acute Postoperative Analgesia (KAPA) pilot study to examine the role of oral ketamine in improving recovery after spine surgery.

Conditions

Postoperative Pain

Keywords

Postoperative; pain; effective; safe; Ketamine; placebo

Outcome Measures

Primary Outcomes (1)

• Recovery After Surgery

  The Quality of Recovery-15 is a self-reported, patient centered outcome metric. The questionnaire has been psychometrically tested and validated. It has been shown to have good content validity, internal consistency and reliability. It captures five domains of recovery after surgery including pain, physical independence, psychological support and emotional state. It can be printed on a single sheet of paper and is easily administered in under three minutes. A change in 8 points on the score has been defined as the minimally important clinical difference in a previous study.

  30 days

Secondary Outcomes (4)

• Opioid Use

  30 days

• Pain Intensity

  30 days

• Pain Interference

  30 days

• Mood

  3 days

Study Arms (2)

Study Group 1

EXPERIMENTAL

Patient will receive Ketamine at a dose of 30 mg every eight hours. It will be mixed with apple juice prior to administration and taken orally. Patients will receive Ketamine for three days or nine doses total.

Drug: Ketamine

Study group 2

PLACEBO COMPARATOR

Patient will receive Placebo at a matching dose every eight hours. It will be mixed with apple juice prior to administration and taken orally. Patients will receive Placebo for three days or nine doses total.

Other: Placebo

Interventions

Ketamine DRUG

The use of oral Ketamine in this study is experimental.This study will look at how effective and safe Ketamine.

Also known as: Ketamine Group

Study Group 1

Placebo OTHER

A placebo is given in this study to reduce the chances of believing that pain after surgery is getting better because one is receiving oral Ketamine

Also known as: Placebo group

Study group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-75 undergoing multi-level lumbar fusion and decompression
• Planned overnight admission to hospital

You may not qualify if:

• Patients taking greater than 90 milligram morphine equivalents
• History of substance use disorder
• Previous surgery within six months
• Pre-existing renal or liver impairment
• Chronic benzodiazepine use
• Psychiatric disorder with current/active pharmacologic treatment
• Inability to complete questionnaires

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

TWH/UHN

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michael Dinsmore, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The KAPA trial will be a single center, blinded (participant, caregiver, investigator, outcome assessor), parallel arm, randomized controlled feasibility trial of patients undergoing spine surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a two arm, randomized controlled trial with a target enrollment of forty patients. Randomization will be performed with a 1:1 allocation with Ketamine or Placebo.

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 30, 2020
• Study Start: November 17, 2020
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: May 21, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)