Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01966172

Enrollment

180

Registered

2013-10-21

Start date

2007-03-31

Completion date

2009-12-31

Last updated

2013-10-21

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

Conditions

Analgesia, Postoperative Pain

Keywords

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

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.

Interventions

DRUGIbuprofen

oral ibuprofen 400mg 4 times daily

DRUGGabapentin

Oral Gabapentin 300mg twice daily

DRUGMorphine

10 mg morphine orally 4 times daily

DRUGParacetamol

oral paracetamol 1000mg four times daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Hospital stay in days.	days until discharge	—
Evaluation of side-effects by daily questionnaire	4th postoperative day	—
Additional analgesic consumption	4th postoperative day	—
Other complications	30th postoperative day	i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications.
30 day Mortality	30th postoperative day	Death from all causes.
Cardiac complications	30th postoperative day	i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026