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Introduction: Improving postoperative pain management after spinal surgery is a significant challenge for surgeons and anesthesiologists. Pain following spinal surgery, can lead to significant morbidity, limit early mobility, and increase the risk of chronic pain. This trial examines the analgesic effects of dexamethasone as an adjuvant to ropivacaine in wound infiltration after lumbar surgery.
Methods: In this study, we randomly assigned sixty patients undergoing lumbar laminectomy and/or osteosynthesis into two groups of 30 patients each. The control group (R-group) received only Ropivacaine (150 mg of Ropivacaine 7.5% (20 ml) added to 2 ml of normal saline in the wound infiltration), while the intervention group (RD-group) received Ropivacaine with the addition of dexamethasone (150 mg of Ropivacaine 7.5% (20 ml) added to 8 mg of dexamethasone in the wound infiltration). Both groups were administered patient-controlled analgesia (PCA) with morphine for self-medication.
Postoperatively, a blinded evaluator assessed pain at H0, recorded the assessment of surgical scar pain using the Visual Analog Scale (VAS) at 4, 6, 12, 24, and 48 hours, as well as the time to the first opioid request, cumulative morphine consumption, opioid-related side effects, and length of stay. All patients were scheduled for a 3-month follow-up call to monitor chronic pain progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine 0.75% Injectable Solution | Experimental | Wound Infiltration for Postoperative Analgesia After Spinal Surgery |
|
| Dexamethasone 8mg | Experimental | Wound Infiltration for Postoperative Analgesia After Spinal Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.75% Injectable Solution | Drug | WOUND INFILTRATION AFTER SPINAL SURGERY |
|
| Measure | Description | Time Frame |
|---|---|---|
| the time of the first analgesic demand of PCA | Change of VAS scores at 4, 6, 12, 24, and 48 hours postoperatively were also assessed by the patients after they had recovered from anesthesia | at 4, 6, 12, 24, and 48 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ATEF BEN NSIR, PHD | HOPITAL UNIVERSITAIRE FATTOUMA BOURGUIBA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Fattouma Burguiba Monastir | Monastir | 5000 | Tunisia |
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| dexamethasone 8mg | Drug | WOUND INFILTRATION AFTER SPINAL SURGERY |
|
|
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D007405 | Intervertebral Disc Displacement |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012847 | Single Person |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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