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Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.
Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaine 0.2%, wound infusion | Experimental |
| |
| saline solution 0.9%, wound infusion | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| morphine consumption | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients in need of morphine in post surgery monitoring room | 1 hour after surgery | |
| morphine consumption in post surgery monitoring room | 1 hour post surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Departement of Anesthesia and Intensive Care | Grenoble | Auvergne-Rhône-Alpes | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26865083 | Derived | Greze J, Vighetti A, Incagnoli P, Quesada JL, Albaladejo P, Palombi O, Tonetti J, Bosson JL, Payen JF. Does continuous wound infiltration enhance baseline intravenous multimodal analgesia after posterior spinal fusion surgery? A randomized, double-blinded, placebo-controlled study. Eur Spine J. 2017 Mar;26(3):832-839. doi: 10.1007/s00586-016-4428-1. Epub 2016 Feb 10. |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Saline solution 0.9% | Drug | wound infusion, 0.9%, bolus 10mL followed by 8 mL/h |
|
| consumption of morphine |
| 72 hours after surgery |
| global self appreciation of pain management | at 72 hours |
| Time required for post surgery functional recovery | participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
| Adverse effects of morphine | 72 hours after surgery |
| hospitalization delay | participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
| asked bolus divided by delivered bolus | until 72 hours after surgery |
| Score for pain intensity | until 72 hours after surgery |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |