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Prospective randomised trial assessing whether intraoperative application of steroids leads to better clinical outcomes in patients submitted to lumbar discectomy
Prospective randomised trial assessing whether intraoperative application of steroids leads to better clinical outcomes in patients submitted to lumbar discectomy A control group has hernia removal without preoperative application of dexamethasone whilst 2 mL of dexamethasone is applied to the intervention group after hernia removal The investigators evaluated outcomes through back and leg NRS 48h, 2 weeks, 1 month and 3 months after surgery and ODI at 1 and 3 months post op
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | Patients undergoing full-endoscopic lumbar discectomy receiving epidural saline. |
|
| Dexamethasone group | Experimental | Patients undergoing full-endoscopic lumbar discectomy receiving epidural dexamethasone 8 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Drug | patients given intraoperative dexamethasone after hernia removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| NRS back and NRS leg | back and leg pain measured by a numerical rating scale. the NRS is a 0 to 10 scale in which 10 means the highest pain score | patients will be evaluated over a 3 month period postoperatively, first at 48 hours post surgery, then 2 weeks and 1 month after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| ODI | Oswestry disability index. he ODI is a 0 to 100 scale in which 100 represents the highest level of disability and 0 the lowest level of disability. | patients will be evaluated over a 3 month period postoperatively, first at 1 month and then 3 months. |
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Inclusion Criteria:
Adult patients (≥18 years) Undergoing single-level full-endoscopic lumbar discectomy Symptomatic lumbar disc herniation Ability to provide written informed consent
Exclusion Criteria:
Previous lumbar surgery at the same level Foraminal or extraforaminal disc herniations Multilevel surgery Intraoperative conversion to microdiscectomy Dural tear precluding epidural steroid application
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Universitario São João | Porto | Porto District | 4445 | Portugal |
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| Control group (Normal Saline) (C) | Other | patients given 2mL saline |
|
| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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