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Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

Primary Purpose

Analgesia, Postoperative Pain

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Ibuprofen

Gabapentin

Morphine

Paracetamol

About this trial

This is an interventional treatment trial for Analgesia focused on measuring NSAID, gabapentin, multimodal, morphine, dexamethasone, cardiac surgery, postoperative pain, analgesia.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rigshospitalet, Copenhagen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal

Morphine

Arm Description

oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily

oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily

Outcomes

Primary Outcome Measures

Evaluation of analgesic effect by 11-NRS scale

assessement of analgesic effect for the first 4 days after surgery

Secondary Outcome Measures

Additional analgesic consumption

Hospital stay in days.

Evaluation of side-effects by daily questionnaire

Cardiac complications

i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation.

Other complications

i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications.

30 day Mortality

Death from all causes.

Full Information

NCT ID

NCT01966172

First Posted

September 30, 2013

Last Updated

October 16, 2013

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01966172

Brief Title

Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

Official Title

Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia, Postoperative Pain

Keywords

NSAID, gabapentin, multimodal, morphine, dexamethasone, cardiac surgery, postoperative pain, analgesia.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multimodal

Arm Type

Experimental

Arm Description

oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily

Arm Title

Morphine

Arm Type

Active Comparator

Arm Description

oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Other Intervention Name(s)

non-selective Non-steroid antiinflammatory drug (NSAID)

Intervention Description

oral ibuprofen 400mg 4 times daily

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Intervention Description

Oral Gabapentin 300mg twice daily

Intervention Type

Drug

Intervention Name(s)

Morphine

Other Intervention Name(s)

An opiod

Intervention Description

10 mg morphine orally 4 times daily

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Intervention Description

oral paracetamol 1000mg four times daily

Primary Outcome Measure Information:

Title

Evaluation of analgesic effect by 11-NRS scale

Description

assessement of analgesic effect for the first 4 days after surgery

Time Frame

4th postoperative day

Secondary Outcome Measure Information:

Title

Additional analgesic consumption

Time Frame

4th postoperative day

Title

Hospital stay in days.

Time Frame

days until discharge

Title

Evaluation of side-effects by daily questionnaire

Time Frame

4th postoperative day

Title

Cardiac complications

Description

i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation.

Time Frame

30th postoperative day

Title

Other complications

Description

i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications.

Time Frame

30th postoperative day

Title

30 day Mortality

Description

Death from all causes.

Time Frame

30th postoperative day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Skov Olsen, MD,PhD,DMSc

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sulman Rafiq, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

Rigshospitalet, Copenhagen University Hospital

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

24650125

Citation

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.

Results Reference

derived

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Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

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