A Comparison of Intra-op Ketamine vs Placebo in Patients Having Spinal Fusion

NCT02424591 | Completed Phase 4 Results DMC

• 1 other identifier: 14-00599
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is severe after major spine surgery. Opioids such as morphine and hydromorphone are routinely used for postoperative pain control. These drugs have significant side effects, most importantly respiratory depression, nausea, constipation and tolerance. Moreover, many spine surgery patients have used opioid pain medication for back pain long term, leading to pre-surgical opioid tolerance and increased postoperative pain. This has led to a search for adjuvant medications to reduce the use of opioids and reduce opioid mediated side effects and tolerance. Ketamine is an intravenous anesthetic with analgesic properties in subanesthetic doses. Ketamine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. NMDA receptors are involved in central pain sensitization via wind-up phenomenon and altered pain memory, a process which can be blocked by ketamine. NMDA receptor antagonists may prevent the development of tolerance to opioids and hyperalgesia. Ketamine has been safely used to decrease pain in numerous studies. Ketamine can also act as an antidepressant with hours of administration. Ketamine has rapid brain uptake and subsequent re-distribution with a distribution half-life of 10-15 minutes and an elimination half-life of 2 hours. Ketamine does not cause respiratory depression.

Conditions

Postoperative Pain

Keywords

Anesthesia Recovery Period; Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• Scores on Questionnaires

  Quality of Recovery 15 questions questionnaires that ask, on a scale of 0-10, with 0 always being bad and 10 always being best, how the patient is recovering. The total number is reviewed, so the highest total score possible is 150 and the lowest is 0.

  Post-op Day 3

Secondary Outcomes (2)

• Pain Score

  Post-op Day 3

• Beck's Depression Inventory

  Post-op Day 3

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

ketamine group will be infused after intubation and terminated at the start of skin closure

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

placebo group will have standard of care rather than ketamine infusion

Other: Placebo

Interventions

Ketamine DRUG

Infusion at a rate of 10 mcg/kg/min

Also known as: Ketalar

Ketamine

Placebo OTHER

Placebo IV

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult (\>/=18)
• male or female
• Undergoing surgery for multilevel (\>2 level) spinal fusion from a posterior approach.
• General anesthesia
• English speakers such that they can complete the pain score and satisfaction questionnaires whose scores are a critical outcome variable.
• If female, subject is non-lactating and is either: a. Post-menopausal or post hysterectomy; b. Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
• Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.

You may not qualify if:

• Cognitively impaired (by history)
• Subject with a history of psychosis
• Subject known to have significant hepatic disease
• Subject for whom opioids or ketamine are contraindicated
• Patients with narrow angle glaucoma
• Increased intracranial or intraocular pressure
• If female, is either pregnant or lactating.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

Related Publications (6)

• Woolf CJ, Thompson SWN. The induction and maintenance of central sensitization is dependent on N-methyl-D-aspartic acid receptor activation; implications for the treatment of post-injury pain hypersensitivity states. Pain. 1991 Mar;44(3):293-299. doi: 10.1016/0304-3959(91)90100-C.

  PMID: 1828878 BACKGROUND

• Mao J, Price DD, Mayer DJ. Mechanisms of hyperalgesia and morphine tolerance: a current view of their possible interactions. Pain. 1995 Sep;62(3):259-274. doi: 10.1016/0304-3959(95)00073-2.

  PMID: 8657426 BACKGROUND

• Bell RF, Dahl JB, Moore RA, Kalso E. Perioperative ketamine for acute postoperative pain. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004603. doi: 10.1002/14651858.CD004603.pub2.

  PMID: 16437490 BACKGROUND

• Machado-Vieira R, Salvadore G, Diazgranados N, Zarate CA Jr. Ketamine and the next generation of antidepressants with a rapid onset of action. Pharmacol Ther. 2009 Aug;123(2):143-50. doi: 10.1016/j.pharmthera.2009.02.010. Epub 2009 May 3.

  PMID: 19397926 BACKGROUND

• Yamauchi M, Asano M, Watanabe M, Iwasaki S, Furuse S, Namiki A. Continuous low-dose ketamine improves the analgesic effects of fentanyl patient-controlled analgesia after cervical spine surgery. Anesth Analg. 2008 Sep;107(3):1041-4. doi: 10.1213/ane.0b013e31817f1e4a.

  PMID: 18713926 BACKGROUND

• Loftus RW, Yeager MP, Clark JA, Brown JR, Abdu WA, Sengupta DK, Beach ML. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010 Sep;113(3):639-46. doi: 10.1097/ALN.0b013e3181e90914.

  PMID: 20693876 BACKGROUND

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: John Ard, MD
• Organization: NYU School of Medicine

john.ard@nyumc.org

212.263.5072

Study Officials

• John Ard, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 23, 2015
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)