AdverseEvent, Morphine, Pain Relief, Spine Surgery
Conditions
Brief summary
: Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. The investigators hypothesized that eructor nerve block induced a large block from L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after surgery.
Interventions
DRUGLocal administration of ropivacaine
Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery
DRUGLocal administration of placebo (saline solution)
injection of saline solution in addition with conventional anesthesia for spine surgery
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age\> 18years and \<80 years * lumbar spine surgery (2-4 levels) * posterior approach * ASA 1-3
Exclusion criteria
* refusal * age \< 18yrs * \<50 kg and \>120 kg * pregnant * renal or hepatic severe desease * ASA 4 * no French speaking * emergency surgery * local or systemic infection * surgical resumption of the surgical site * surgery involving a thoracic approach * allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| morphine consumption (mg) | 24 Hours after surgery | Quantity administered in the post-interventional monitoring room and in hospitalization via a self-controlled morphine pump by the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain at rest and at movement: Visual Analogic scale | Day 1 to Day 3, Day od hospital discharge and month 3 | Visual Analogic scale of pain (0-10) |
| chronic pain: DN4 questionnaire | Questionnaire DN4 at 3 months | pain score as mesured with DN4 questionnaire |
| Length of hospital stay | hospital length of stay, an average of 4 days | Number of day in hospital |
| Adverse events | from surgery to 3 months | Nausea, vomiting, confusion, urinary retention, hematoma, reintervention |
| Patient Satisfaction: visual analogic scale | Day of hospital discharge, an average of day 4 | Patient satisfaction mesured with a visual analogic scale (0-10) |
| Patient Quality of life: EQ-5D Questionnaire | 3 months | Patient Quality of life mesured with EQ-5D Questionnaire |
| Length of stay in the post-intervention care unit | Day 1 | Number of minutes that patient stay in post intervention care unit in minutes |
Countries
France
Outcome results
None listed