Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

• ClinicalTrials.gov Identifier: NCT01966172
• Recruitment Status: Completed
• First Posted: October 21, 2013
• Last Update Posted: October 21, 2013
• Sponsor: Rigshospitalet, Denmark
• Information provided by (Responsible Party): Sulman Rafiq, Rigshospitalet, Denmark

Tracking Information

• First Submitted Date: September 30, 2013
• First Posted Date: October 21, 2013
• Last Update Posted Date: October 21, 2013
• Study Start Date: March 2007
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 16, 2013)

Evaluation of analgesic effect by 11-NRS scale [ Time Frame: 4th postoperative day ]

assessement of analgesic effect for the first 4 days after surgery

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 16, 2013)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Analgesia
• Postoperative Pain

Intervention

• Drug: Ibuprofen
  oral ibuprofen 400mg 4 times daily
  Other Name: non-selective Non-steroid antiinflammatory drug (NSAID)
• Drug: Gabapentin
  Oral Gabapentin 300mg twice daily
• Drug: Morphine
  10 mg morphine orally 4 times daily
  Other Name: An opiod
• Drug: Paracetamol
  oral paracetamol 1000mg four times daily

Study Arms

• Experimental: Multimodal
  oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily
  Interventions:

  • Drug: Ibuprofen
  • Drug: Gabapentin
  • Drug: Paracetamol
• Active Comparator: Morphine
  oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily
  Interventions:

  • Drug: Morphine
  • Drug: Paracetamol

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 16, 2013): 180
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01966172
• Other Study ID Numbers: Smerte1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sulman Rafiq, Rigshospitalet, Denmark
• Original Responsible Party: Same as current
• Current Study Sponsor: Rigshospitalet, Denmark
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Peter Skov Olsen, MD,PhD,DMSc; Rigshospitalet, Denmark
• Study Chair: Sulman Rafiq, MD; Rigshospitalet, Denmark

• PRS Account: Rigshospitalet, Denmark
• Verification Date: October 2013