Fusion of Spine, Lumbar Region
Conditions
Brief summary
The goal of this interventional study is to is to compare the effect of a tap block versus a placebo in patients undergoing anterior lumbar spine surgery. The main question it aims to answer : • whether tap block can reduce the need for postoperative pain medication Participants will be randomized into two groups and all postoperative pain medication will be recorded over 3 days. Researchers will compare tap block vs placebo to see if it reduces postoperative pain.
Interventions
DRUGLevobupivacaine
Patients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml
OTHERPlacebo Tap block
Patients in the placebo arm will receive an injection of salin solution 2.5mg/ml , in the same way as tap block
Sponsors
Clinique Saint Jean, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient affiliated or entitled to a social security plan. * Patient who has been informed about the study and has co-signed a consent form with the investigator. consent to participate in the study. * Patients over 18 years of age scheduled for abdominal disc surgery on one or two levels. * Patient with ASA criteria 1, 2 and 3.
Exclusion criteria
* Patients with intolerance or contraindication to paracetamol, anti-inflammatory or morphine. * Patients allergic to local anesthetics. * Pregnant or breast-feeding patient. * patient undergoing cancer or trauma surgery trauma. * Patient participating in another interventional study. * Patient with a history of lumbar arthrodesis. * Patient refusing to sign consent form. * Patient unable to give informed consent. * Patient under court protection, guardianship or trusteeship. * Patient not available for study follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic consumption | 72hours | The use of analgesics (oral or venous) during the during the 72 hours following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment will be reported for 72 hours after surgery measured on a Visual analogue scale between 0 and 10 | 72hours | Pain assessment for 72 hours after surgery, measured on a scale between 0 and 10 (VAS scale ), where 0 is no pain and 10 is maximum pain |
Countries
France
Outcome results
None listed