Plain English Summary
Background and study aims
Spinal fusion surgery involves joining together bones in the spine so there is no movement between them. Common analgesics (painkillers) such as paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) are rarely effective on their own after spinal fusion surgery. Opioids are the most effective analgesics but they have many side effects, such as vomiting and constipation. Ketamine is an old anaesthetic drug that also has analgesic properties. Ketamine reduces the need for opioids after the operation and therefore helps to reduce the side effects caused by opioids. However, the ideal dose of ketamine is not known. The aim of this study is to determine the best dose of ketamine to use to reduce the need for opioids while avoiding side effects.
Who can participate?
Patients aged over 18 undergoing elective posterior lumbar fusion surgery
What does the study involve?
Participants are randomly allocated into three groups. The first group are given placebo (a dummy drug) during the operation. The second and third groups are given different doses of ketamine during the operation. After the operation the participants’ need for opioid medication is recorded.
What are the possible benefits and risks of participating?
Participants treated with ketamine may benefit from improved pain relief (analgesia) after spinal fusion surgery along with fewer side effects caused by opioid medication. Possible risks are side effects caused by ketamine. The most common side effect of ketamine is altered mental state. However, that can be prevented using the drug diazepam.
Where is the study run from?
Helsinki University Central Hospital Töölö Hospital and Pain Clinic (Finland)
When is the study starting and how long is it expected to run for?
January 2013 to December 2014
Who is funding the study?
Helsinki University Central Hospital (Finland)
Who is the main contact?
Dr Elina Jokinen
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KETTO201200074726
Study information
Scientific title
Administration of S-Ketamine during spinal surgery to reduce postoperative pain
Acronym
KETTO
Study hypothesis
It is known that administration of ketamine during surgery reduces the need of opioid medication in the postoperative period. However, the ideal dose of ketamine is not known.
Hypothesis: The more ketamine is being administered during surgery, the greater is the opioid-sparing effect in the postoperative period. However, it is assumed that the number of side effects is also greater.
Ethics approval
Valtakunnallinen lääketieteellinen tutkimuseettinen toimikunta TUKIJA, 12/03/2012, ref: 36/06.00.01/2012
Study design
Prospective randomized double-blinded placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Optimal dose of S-ketamine to reduce the need of opioid medication in the postoperative period
Intervention
The study will involve 192 adult patients undergoing elective posterior lumbar fusion surgery. The patienst will be randomized into three groups: 64 patients will be given placebo (NaCl 0,9%), 64 patients will be given an infusion of S-ketamine 2ug/kg/min and 64 patients will be given an infusion of S-ketamine 10ug/kg/min during the surgery. The consumption of oxycodone with PCA-device is being registered 48-hours after the surgery.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Evaluate the effect of different dosages of S-ketamine in the intraoperative period on the need of postoperative opioid medication
Secondary outcome measures
Evaluate the postoperative confusion, pain and depression in the different study groups
Overall trial start date
01/01/2013
Overall trial end date
31/12/2014
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients (18 years and older) undergoing elective posterior lumbar fusion surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
192
Participant exclusion criteria
1. BMI>35
2. Unstable ischaemic cardiac disease
3. Increased intracranial pressure
4. Increased intraocular pressure
5. Gravidity
6. Lactation
7. Hypersensivity or allergy to ketamine, oxycodone, propofol or remifentanil
8. Severe psychiatric disease
9. Unwillingness or unability to ude PCA-device
10. Inability to use NRS-pain scale
Recruitment start date
01/01/2013
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Finland
Trial participating centre
Helsinki University Central Hospital
Helsinki
00251
Finland
Sponsor information
Organisation
Helsinki University Central Hospital (Finland)
Sponsor details
c/o Vesa Kontinen
Pain management
Haartmaninkatu 2A
Helsinki
00029
Finland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Helsingin ja Uudenmaan Sairaanhoitopiiri
Alternative name(s)
Helsinki University Central Hospital, HUS
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Finland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary