Status:
COMPLETED
Local Anesthetic Infiltration to Prevent Postoperative Pain After Lumbar Surgery
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Hyperalgesia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's postoperative reconvalescence especially functional rehabilitation. Efficient and safe methods for postoperative ana...
Detailed Description
Blockade of parietal nociceptive afferents by the use of continuous wound infiltration with local anesthetics may be beneficial in a multimodal approach to postoperative pain management after major su...
Eligibility Criteria
Inclusion
- Necessity to use safety contraceptive methods for women who can procreate
- Patients with American Society of Anesthesiologists physical status I, II or III
- Patients scheduled to undergo a posterior lumbar arthrodesis on one at three levels treated,
- Posterior lumbar arthrodesis is only executed on lumbar degenerative spine,
- A written informed consent has to sign by the patient and the investigator before beginning clinical study
- Patients affiliated with social security system
Exclusion
- Pregnancy and breast-feeding
- Posterior lumbar arthrodesis exceeding three levels treated,
- Posterior lumbar arthrodesis post-traumatic or with neoplastic disorders or with the aim of correcting cord compression,
- Epilepsy not controlled through medication,
- Preoperative cognitive dysfunction or psychiatric disorders,
- Cardiac or breathing dysfunctions,
- Preoperative opioid consumption,
- Patients who have a known local anesthetic, or morphine or/and acetaminophen allergy,
- Lack of understanding about the study or inability to use the patient controlled analgesic device,
- Patients protected by the law, guardianship,
- Patients who take a share in an another clinical study in the same time,
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00825422
Start Date
January 1 2009
End Date
August 1 2010
Last Update
June 20 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital
Bordeaux, France, 33076