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

The effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004181-18-DK

Enrollment

Unknown

Registered

2012-11-23

Start date

2012-11-23

Completion date

Unknown

Last updated

2016-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients set to lumbar prolapse surgery in general anesthesia MedDRA version: 14.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Dexagalen Product Name: Dexamethason Pharmaceutical Form: Solution for injection Other descriptive name: DEXAMETHASONE Pharmaceutical form of the placebo: Solution for injection Route of a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age> 18 years and 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery ;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	—

Measure

Time frame

Main Objective: To investigate the effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery ;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

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Secondary

Measure	Time frame
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. • 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. • Pain score at rest and during active mobilization on time 48 hours postoperatively. • the degree of nausea at time 2, 4, 8, 12, 24, and 48 hours postoperatively • Number of vomiting during the periods 0-2, 2-4, 4-8. 8-12, 12-24, 24-48 hours post-operatively. • Consumption of Zofran between 0-24 and 24-48 hours post-operatively. • the degree of sedation at time 2, 4, 8, 12, 24, and 48 hours postoperatively. • 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	—

Measure

Time frame

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. • 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. • Pain score at rest and during active mobilization on time 48 hours postoperatively. • the degree of nausea at time 2, 4, 8, 12, 24, and 48 hours postoperatively • Number of vomiting during the periods 0-2, 2-4, 4-8. 8-12, 12-24, 24-48 hours post-operatively. • Consumption of Zofran between 0-24 and 24-48 hours post-operatively. • the degree of sedation at time 2, 4, 8, 12, 24, and 48 hours postoperatively. • 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

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Countries

Denmark

Contacts

Public ContactClinical Trial Information

Rigshospitalet, Dept. of Anaesthesia 4231

rikkesoennichsen@gmail.com+4535459502

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026