Multimodal Analgesic Treatment Versus Traditional Morphin... | NCT01966172

Studies
Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

NCT01966172

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Oct 21, 2013Estimated

Enrollment

180Actual

Phase

Phase 4

Conditions

Analgesia
Postoperative Pain

Interventions

Ibuprofen
Gabapentin
Morphine
Paracetamol

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Aug 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 30, 2013

First Submission Date that Met QC Criteria

Oct 16, 2013

First Posted Date

Oct 21, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2013

Last Update Posted Date

Oct 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To test if multimodal analgesia with different analgesic medication offer better pain relief, lesser side effects and is safe compared to conventionel opiod analgesia after cardiac surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multimodal	Experimental	oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily	Drug: Ibuprofen Drug: Gabapentin Drug: Paracetamol
Morphine	Active Comparator	oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily	Drug: Morphine Drug: Paracetamol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ibuprofen	Drug	oral ibuprofen 400mg 4 times daily	Multimodal	non-selective Non-steroid antiinflammatory drug (NSAID)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of analgesic effect by 11-NRS scale	assessement of analgesic effect for the first 4 days after surgery	4th postoperative day

Secondary Outcomes

Measure	Description	Time Frame
Additional analgesic consumption		4th postoperative day
Hospital stay in days.		days until discharge
Evaluation of side-effects by daily questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age>18
any cardiac procedure with sternotomy
able to give informed consent

Exclusion Criteria:

cardiac surgery without sternotomy
peripheral neuropathy
neurological disease
psychiatric illness
history of GI bleeding
chronic pain (i.e. back pain, cancer, arthritis)
serum creatinine >150 μmol/l
hepatic disease with elevated liver enzymes (SGPT and SGOT elevated to 1.5 times maximum normal value)
allergic to study medication
alcohol abuse
abuse of narcotics or medication
pregnancy
participation in other clinical trials
insufficient language skills
In addition intensive care unit (ICU) stay for more than 24 hours was used as a pre-defined post randomization exclusion criteria, because prolonged ICU stay and ventilator treatment would interfere with study analgesic protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Skov Olsen, MD,PhD,DMSc	Rigshospitalet, Denmark	Principal Investigator
Sulman Rafiq, MD	Rigshospitalet, Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet, Copenhagen University Hospital		Copenhagen		2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24650125	Derived	Rafiq S, Steinbruchel DA, Wanscher MJ, Andersen LW, Navne A, Lilleoer NB, Olsen PS. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial. J Cardiothorac Surg. 2014 Mar 20;9:52. doi: 10.1186/1749-8090-9-52.

ID	Term
D000377	Agnosia
D010149	Pain, Postoperative

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D007052	Ibuprofen
D000077206	Gabapentin
D009020	Morphine
D000082	Acetaminophen

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals