Methadone and Ketamine for Spinal Surgery

NCT02827526 | Completed Phase 4

• 1 other identifier: EH15-268
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing major spinal surgery continue to experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Several factors contribute to postoperative pain in this patient population. Many patients present to surgery dependent on relatively high doses of oral opioids; this daily administration leads to tolerance to the effects of these drugs as well as hyperalgesia (exposure to opioids makes subsequent pain worse). In addition, surgical procedures on the spine are very painful. Furthermore, most of the opioids used after surgery only produce analgesia (pain relief) for 2-4 hours, which leads to fluctuations in levels of pain control (patients have to push a button to deliver pain medication when they begin to feel discomfort). Recent data suggest that the use of a long-acting opioid like methadone in the operating room, which provides analgesia for 24-36 hours, may improve pain control after spinal fusion surgery. However, other pain treatment modalities are required in this patient population. Studies have demonstrated that ketamine, a drug that prevents pain by a mechanism different from opioids, is effective in reducing pain medication requirements when given in the perioperative period. Small-dose infusions not only provide analgesia, but also prevent opioid tolerance and hyperalgesia. In particular, the combination of methadone and ketamine may be especially effective in controlling pain in patients following major operations. The aim of this randomized clinical trial is to examine the effect of a low-dose perioperative infusion of ketamine, when given with methadone in the operating room, on postoperative pain medication requirements, pain scores, and clinical recovery characteristics after spinal fusion surgery.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• hydromorphone consumption

  first 24 hours

Secondary Outcomes (4)

• hydromorphone consumption

  second 24 hours

• hydromorphone consumption

  third 24 hours

• postoperative pain

  morning of postoperative day 1

• postoperative pain

  morning of postoperative day 2

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

Patients in the ketamine arm will receive an intraoperative and postoperative infusion of ketamine

Drug: Ketamine

Control

PLACEBO COMPARATOR

Patients in the control arm will receive an intraoperative and postoperative infusion of dextrose

Drug: Control

Interventions

Ketamine DRUG

Ketamine

Control DRUG

Also known as: dextrose infusion

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting for elective posterior spinal fusion surgery (lower thoracic, lumbar, sacral)
• Ages 18-80

You may not qualify if:

• Preoperative renal failure (defined as a serum creatinine \> 2.0 mg/dL.)
• American Society of Anesthesiologists Physical Status IV or V
• Pulmonary disease necessitating home oxygen therapy
• Allergy to methadone, hydromorphone, or ketamine
• Preoperative recent history of opioid or alcohol abuse
• Significant liver disease
• Inability to use a PCA device or speak the English language

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Glenn S Murphy, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: December 21, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)