Condition category
Surgery
Date applied
20/02/2009
Date assigned
15/07/2009
Last edited
15/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mats Karling

ORCID ID

Contact details

Department of Anesthesia
University Hospital of Nothern Sweden
Umeå
SE 90185
Sweden
+46 (0)90 785 0000
mats.karling@vll.se

Additional identifiers

EudraCT number

2008-001642-19

ClinicalTrials.gov number

Protocol/serial number

EudraCT: 2008-001642-19

Study information

Scientific title

Intravenous analgesia with S-ketamine and morphine versus epidural analgesia with fentanyl, bupivacaine and epinephrine: a randomised controlled trial

Acronym

SPIC

Study hypothesis

Patient-controlled intravenous analgesia with morphine and S-ketamine hydrochloride is as effective in pain control with less invasiveness and has comparable or less adverse effects as patient-controlled epidural analgesia with bupivacaine, fentanyl and epinephrine after scoliosis surgery.

Ethics approval

Regional Ethics Board of Umea University, Sweden gave approval on 5th December 2008 (ref: 08-056)

Study design

Randomised 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

Post-operative pain after scoliosis surgery

Intervention

In one arm pain treatment consist of a continued epidural infusion of a mixture of bupivacine 1 mg/ml, epinephrine 2 µg/ml and fentanyl 2 µg/ml with patient controlled extra boluses of 0.1 ml/kg to a maximum 5 ml. Initial bolus will be 0.02 ml/kg/segment (maximum of 15 ml) and an initial infusion rate of 0.2 ml/kg/h (maximum of 15 ml/h). Maximal infusion rate inclusive bolus doses will not exceed 0.4 ml/kg/h. The epidural infusion rate is adjusted according to effect and spread.

In the other arm pain treatment consists of a continues intravenous infusion of (S)-ketaminehydrochlorid 1 mg/ml 0.1 mg/kg/h and will be started after an initial bolus of 0.25 mg/kg. Morphine 1 mg/ml administered as a Patient Controlled bolus intravenous injection of 25 µg/kg lock out time 6 minutes, after an initial repeated boluses of 50 µg/kg until pain is lower than 30 mm measured with Visual Analogue Scale (VAS) (0 - 100 mm). A continuous infusion of morphine will be started at a rate of 10 µg/kg/h. The bolus dose or the infusion rate will be adjusted according to needs. Background infusion may be increased 5 µg/kg/h until a maximum of 25 µg/kg/h.

These treatments will be given for 6 days. Follow up of pain, side effects, bowel function and mobilisation will be as long as the patient is hospitalised (about 9 days) and further 2 weeks at home.

Intervention type

Drug

Phase

Not Applicable

Drug names

Morphine, S-ketamine hydrochloride, bupivacaine, fentanyl, epinephrine

Primary outcome measures

Patients self-report on pain at rest, measured with a Visual Analogue Scale (VAS) (0 - 100 mm, where 0 means no pain and 100 means worst possible pain) every 4 hours during the six first post-operative days.

Secondary outcome measures

1. Pain in motion (during coughing) measured once every 24 hours, VAS (0 - 100 mm)
2. Nausea: defined as 0 = no nausea, 1 = a little nausea, 2 = much nausea, and 3 = vomiting will be monitored every 4 hours and when the patient reports nausea
3. Pruritus defined as: 0 = no pruritus, 1 = pruritus will be monitored when occurring
4. Bowel activity: measured every 12 hours and defined as follows: bowel sounds = 1, first flatus = 2, first tolerated meal = 3, first bowel movement (defined by the patient as defecation) = 4
5. Time to first demanded dose
6. Time to first rescue-analgesia measured from the start of the post-operative study-protocol. Criteria for rescue-administration will be pain, self-report VAS greater than 30 mm in spite of the study protocol for pain management in the respective PCIA and PCEDA groups.
7. Number of demanded PCA-doses
8. Number of rescue doses
9. Total amount of rescue-morphine measured in mg
10. Occurrence of negative psychological effects, as nightmares, hallucinations or confusion
11. A rating of the participants global satisfaction, rated once a day (very satisfied = 0, satisfied = 1, dissatisfied = 2, very dissatisfied = 3)
12. Adherence to mobilisation plan will be recorded daily (0 = plan not fulfilled, 1 = plan fulfilled, 2 = ahead of plan)
13. Length of stay in the hospital (LOS) measured from the day of surgery

Outcome-measures in the follow up study will be:
1. The Trauma Symptom Checklist for Children and the adolescents completed at 1 month after returning home
2. Self-reports of common pain and worst pain, will be rated every day, the first 14 days at home after the surgery
3. The adolescents will write a diary on how they experience the first 14 days at home
4. Interviews will be performed 1 month after the surgery

Overall trial start date

01/04/2009

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Children and adolescents (aged 12 - 18 years, either sex) with idiopathic scoliosis scheduled for correction by posterior spinal fusion.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

38

Participant exclusion criteria

1. Pregnant
2. Allergic to study drugs
3. Unable to present self reports on pain and nausea

Recruitment start date

01/04/2009

Recruitment end date

01/04/2011

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Anesthesia
Umeå
SE 90185
Sweden

Sponsor information

Organisation

University Hospital of Nothern Sweden (Sweden)

Sponsor details

c/o Mats Karling
Department of Anaesthesia
Umeå
SE 90185
Sweden
+46 (0)90 785 0000
mats.karling@vll.se

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

County Council of Västerbotten (Västerbottens läns landsting [VLL]) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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