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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00358-35 | Other Identifier | ID-RCB number, ANSM |
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Spinal fracture surgery is a common surgery. Post-operative pain has been reduced by the advent of so-called minimally invasive techniques. The immediate post-operative pain, however, remains relatively high, mainly because of muscle pain following the trauma.
The erector spinae plane block (ESPB) is a loco-regional anesthesia technique first described in 2016.
A retrospective cohort study showed an improvement in post-operative analgesia of percutaneous osteosynthesis spinal surgery through a reduction in 24-hour morphine use.
In order to prove and confirm the effectiveness of this technique, we will conduct a double-blind randomized controlled study.
The objective will be to demonstrate the analgesic effectiveness of the technique by reducing morphine consumption in post-operative. The expected reduction in morphine consumption is set at 30%, based on the clinical experience developed in our practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erector spinae plane block with naropeine [3,75 mg/mL] | Experimental | Experimental group: Erector spinae plane block with naropeine [3,75 mg/mL] |
|
| Control group : ESPB with saline 0,9% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spinae plane block with naropeine [3,75 mg/mL] | Procedure | Erector spinae plane block Procedure:
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption for the first postoperative 24 hours | Morphine consumption for the first postoperative 24 hours(mg) | during the first 24H after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative morphine consumption | Post-operative morphic consumption (mg) | during the procedure |
| Evolution of postoperative morphine consumption 1 hour | Post-operative morphic consumption (mg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cédric CIRENEI, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro | Lille | 59000 | France |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| ESPB with saline 0,9% | Procedure | Procedure for the Erector spinae plane block Procedure by NaCl 0.9%:
Repetition of the gesture for the transverse controlateral process |
|
| Post-operative morphic consumption (mg) at postoperative 1 hour |
| Evolution of postoperative morphine consumption 3 hours | Post-operative morphic consumption (mg) | Post-operative morphic consumption (mg) at 3 hours |
| Evolution of postoperative morphine consumption 6 hours | Post-operative morphic consumption (mg) | Post-operative morphic consumption (mg) at 6 hours |
| Evolution of postoperative morphine consumption 9 hours | Post-operative morphic consumption (mg) | Post-operative morphic consumption (mg) at 9 hours |
| Evolution of postoperative morphine consumption 12 hour | Post-operative morphic consumption (mg) | Post-operative morphic consumption (mg) at 12 hours |
| Evolution of postoperative pain | Pain evaluation by numerical scale between 0 (none pain) and 10 (worst pain ever) | Every 3 hours during the first 24 hours |
| Duration of stay in postanesthesia care unit (PACU) | Time (minutes) in PACU ; exit criteria = two consecutives Aldrete scores at 10 | when two consecutives Aldrete scores at 10 occure |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |