Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966172
• Other study ID #: Smerte1
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2013
• Last updated: October 16, 2013
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: October 2013
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ibuprofen
oral ibuprofen 400mg 4 times daily
• Gabapentin
Oral Gabapentin 300mg twice daily
• Morphine
10 mg morphine orally 4 times daily
• Paracetamol
oral paracetamol 1000mg four times daily

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Copenhagen University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of analgesic effect by 11-NRS scale	assessement of analgesic effect for the first 4 days after surgery	4th postoperative day	No
Secondary	Additional analgesic consumption		4th postoperative day	No
Secondary	Hospital stay in days.		days until discharge	No
Secondary	Evaluation of side-effects by daily questionnaire		4th postoperative day	No
Secondary	Cardiac complications	i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation.	30th postoperative day	Yes
Secondary	Other complications	i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications.	30th postoperative day	Yes
Secondary	30 day Mortality	Death from all causes.	30th postoperative day	Yes