Condition category
Surgery
Date applied
03/10/2012
Date assigned
10/10/2012
Last edited
20/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Elina Jokinen

ORCID ID

Contact details

Helsinki University Central Hospital
Töölö Hospital
Topeliuksenkatu 5
Helsinki
00251
Finland

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

http://www.hus.fi/

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

Publication citations

Additional files

Editorial Notes

20/07/2016: Plain English summary added.