CompletedPhase 3

Local Anesthetic Infiltration to Prevent Postoperative Pain After Lumbar Surgery

France50 participantsStarted 2009-01

Plain-language summary

Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's postoperative reconvalescence especially functional rehabilitation. Efficient and safe methods for postoperative analgesia are, therefore, mandatory. The application of opioids are the most frequently used therapies for postoperative pain relief but it very often results side effects. Local anesthetic wound infiltration is widely recognized as a useful adjunct in a multimodal approach to postoperative pain management. In the setting of spine surgery, a single bolus administration of a local anesthetic is a useful method (with a reduction in parenteral morphine consumption during the 48 first hours) but has a limited effect because of its short duration of action. Prolonged administration through a multi-holed catheter positioned by the surgeon at the end of the procedure could increase the duration of action and may thereby improve the efficacy of local wound infiltration. Easy and effective, this new modality of administration has expanded the indications for parietal infiltrations toward major painful procedures. We designed this study to determine whether local anesthetic (compared with saline solution) continuous wound infiltration during the first two days after posterior lumbar arthrodesis on degenerative spine, could improve postoperative analgesia at short-term but particularly at mid-term (two months) and long-term (six months), in order to decrease postoperative lumbar pains (resulting in best life quality, opioid consumption limited and rehabilitation hastened) and postoperative hyperalgesia areas. The postoperative analgesic and antihyperalgesic efficacies; the postoperative rehabilitation at mid-term and long term, and the safety of opioid administration and multi-holed parietal catheter will be compared in the two groups (control and study).

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative pain score : Visual Analog Scale (VAS)

Timeframe: Two months after surgery

Trial details

NCT IDNCT00825422

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-04

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