Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery: A Randomized, Double-Blinded, Controlled Trial

Conditions
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Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis, Lumbar Spine Instability

Intervention / Treatment
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* Drug: Ropivacaine 0.75% Injectable Solution
* Drug: dexamethasone 8mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I or II and diagnosed with lumbar disc herniation, lumbar spinal stenosis, or lumbar degenerative spondylolisthesis requiring surgical treatment such as lumbar laminectomy and/or lumbar osteosynthesis. Exclusion Criteria: Patients with altered communication capacity, previous spinal surgery, neuropathic pain, allergy to opioids, dexamethasone, or local anesthetics, active infection or tumor history, traumatic injury, chronic use of steroids or opioids, severe kidney, hepatic, or pulmonary failure, delayed extubation in post-anesthesia care unit (PACU), major bleeding during or after surgery, or surgical revision within the first 24 hours were excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine 0.75% Injectable Solution<br>Wound Infiltration for Postoperative Analgesia After Spinal Surgery | Drug: Ropivacaine 0.75% Injectable Solution<br>* WOUND INFILTRATION AFTER SPINAL SURGERY<br>* Other names: Alone;|
| Experimental: Dexamethasone 8mg<br>Wound Infiltration for Postoperative Analgesia After Spinal Surgery | Drug: Ropivacaine 0.75% Injectable Solution<br>* WOUND INFILTRATION AFTER SPINAL SURGERY<br>* Other names: Alone;Drug: dexamethasone 8mg<br>* WOUND INFILTRATION AFTER SPINAL SURGERY<br>* Other names: with Ropivacaine 0.75% Injectable Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |