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

University Hospital Fattouma Bourguiba

Status and phase: Completed; Phase 4

Conditions: Lumbar Spondylolisthesis; Lumbar Spinal Stenosis; Lumbar Disc Herniation; Lumbar Spine Instability

Treatments: Drug: dexamethasone 8mg; Drug: Ropivacaine 0.75% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05871073

PAIN MANAGMENT IN SURGERY

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Ropivacaine 0.75% Injectable Solution

Experimental group

Description:

Wound Infiltration for Postoperative Analgesia After Spinal Surgery

Treatment:

Drug: Ropivacaine 0.75% Injectable Solution

Dexamethasone 8mg

Experimental group

Description:

Wound Infiltration for Postoperative Analgesia After Spinal Surgery

Treatment:

Drug: Ropivacaine 0.75% Injectable Solution

Drug: dexamethasone 8mg