The effect of dexamethasone in combination with paracetamol and ibuprofen for analgesia after surgery for herniated

Phase 1

• Conditions: Patients set to lumbar prolapse surgery in general anesthesia; MedDRA version: 14.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-004181-18-DK
• Lead Sponsor: Rigshospitalet; Department of Anaesthesia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-23
• Last Update Posted: 27 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age> 18 years and <85 years
• Patients set to lumbar prolapse surgery in general anesthesia
• Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations in full.
• ASA 1-3.
• BMI> 18 and <40
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Patienter som ikke kan samarbejde til undersøgelsen.
•Patienter som ikke forstår eller taler dansk.
•Allergi over for de i undersøgelsen anvendte stoffer.
•Alkohol- og/eller medicinmisbrug – efter investigators skøn.
•Patienter som er tidligere rygopererede.
•Dagligt forbrug af stærke opioider (morfin, ketogan, oxynorm, metadon,
fentanyl).
Fast per oral steroid behandling.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery<br>;Secondary Objective: Not Applicable;Primary end point(s): Pain Score of active mobilization (VAS) defined by standardized moving from a lying position to sitting on the edge of the bed on time 2, 4, 8, 12 and 24 hours, calculated as the area under the curve (AUC) from 2-24 hours postoperatively.;Timepoint(s) of evaluation of this end point: pain score at the time 2, 8, 12 24 and 48 hours after administration of study drug

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The total need for morphine from 0 to 24 hours post-operatively, administered as patient-controlled pain (bolus 2.5 mg, lockout 10 minutes) and escape morphine.<br> • in the resting pain score (VAS) at time 2, 4, 8, 12 and 24 hours, calculated as the area under the curve (AUC) from 2 to 24 hours postoperatively.<br> • Pain score at rest and during active mobilization on time 48 hours postoperatively.<br> • the degree of nausea at time 2, 4, 8, 12, 24, and 48 hours postoperatively<br> • Number of vomiting during the periods 0-2, 2-4, 4-8. 8-12, 12-24, 24-48 hours post-operatively.<br> • Consumption of Zofran between 0-24 and 24-48 hours post-operatively.<br> • the degree of sedation at time 2, 4, 8, 12, 24, and 48 hours postoperatively.<br> • sleep quality assessed 24 hours post-operatively on a visual scale of 0 to 100 mm, where 0 = best possible sleep, and 100 = worst sleep.;Timepoint(s) of evaluation of this end point: 2,4,8,12,24 and 48 hours after administration og studydrug