Effects of Nefopam on Hyperalgesia After Cardiac Surgery

NCT00413257 | Completed Phase 2 DMC

• 2 other identifiers: 78132005-033
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain after major surgery is consecutive not only to the nociceptive inputs coming from the surgical lesion, but also to peripheral and central neuronal sensitization. This lead to postoperative hyperalgesia and allodynia that are enhanced by the per operative use of high opioid doses. Anti-NMDA drugs have been reported as able to reduce this sensitization process and then to decrease acute morphine tolerance during the postoperative period. Nefopam has been lately shown to combine in experimental trials analgesic and anti hyperalgesic effects. The aim of this study is to compare anti-hyperalgesic effects of nefopam given either before incision and continuously for the following 48hours or starting from the end of the surgery and given for 48hours to a control group that would receive placebo for 48hours. Postoperative analgesia will be based on morphine PCA. Pain scores, hyperalgesia, allodynia, postoperative morphine consumption, and development of chronic pain will be the main criteria that will be evaluated during this study

Conditions

Hyperalgesia; Pain, Postoperative; Pain, Chronic Disease

Keywords

Postoperative Hyperalgesia; cardiac Surgical Procedures; Nefopam; Randomized Controlled Trials; Pain and chronic disease

Outcome Measures

Primary Outcomes (1)

• Nociceptive threshold evaluated with Von Frey mechanical dynamic stimulation. This will start 10cm far from the wound on a perpendicular line to the wound and will be conducted by 1cm step to the wound until the patient explains the stimulation

  H 24

Secondary Outcomes (4)

• static hyperalgesia with Von Frey stimulation 1cm far from the middle of the wound, on the right side of the wound.

  1, 2, 4 and 7 days after intervention

• Morphine consumption

  over the 48 H postoperative

• Pain scores evaluation

  Acute pain (1, 2, 4 and 7 days after intervention) / Chronic Pain (3, 6 and 12 month)

• Cognitive functions evaluation

  1, 2, 4 and 7 days after intervention

Study Arms (3)

1

EXPERIMENTAL

nefopam infusion will start before the surgical incision, at the induction time of anesthesia and will be continued until postoperative H48

Drug: Nefopam

2

EXPERIMENTAL

nefopam administration will start at the end of the surgery and will be continued until postoperative H48

Drug: néfopam

3

PLACEBO COMPARATOR

control group that will receive a placebo from the induction time of anesthesia until H48

Drug: Placebo comparator

Interventions

Nefopam DRUG

0,3mg/kg IV bolus preoperative and 65 µg/kg/h during H48 postoperative

1

néfopam DRUG

bolus Néfopam (0,3mg/kg) during 10 min at the end of surgery and 65 µg/kg/h during postoperative H48

2

Placebo comparator DRUG

bolus NaCl during 10 min at the end of surgery and during postoperative H48

3

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• ASA score: 1-3
• Patients scheduled for Cardiac surgery with median sternotomy for : single valve replacement or Bentall or Benson or Tyron David surgery, single or multiple Cardiac Artery Bypass Grafting (CABG) , combined surgery (valve replacement + CABG) without preoperative risk of postoperative complications
• Informed consent obtained from the patient

You may not qualify if:

• Drug or alcohol abuse history
• Analgesic or opioid consumption within the 12hs preceding the surgery
• Chronic use of analgesic drugs or history of chronic pain
• Convulsion or epilepsy history
• Glaucoma history
• Disability to understand morphine PCA use
• Allergy to nefopam

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Département d'Anesthésie-Réanimation II - Hôpital cardiologique - Groupe Hospitalier Sud, CHU de Bordeaux - 4, Av de Magellan

Pessac, 33604, France

Location

Related Publications (1)

• Richebe P, Picard W, Rivat C, Jelacic S, Branchard O, Leproust S, Cahana A, Janvier G. Effects of nefopam on early postoperative hyperalgesia after cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Jun;27(3):427-35. doi: 10.1053/j.jvca.2012.08.015. Epub 2012 Oct 12.

  PMID: 23063945 DERIVED

MeSH Terms

Conditions

Hyperalgesia; Pain, Postoperative; Pain; Chronic Disease

Interventions

Nefopam

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Disease Attributes

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Philippe RICHEBE, Dr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, Dr

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: November 1, 2008
• Last Updated: May 28, 2010

Record last verified: 2010-05

Locations

FR (1)