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

Phase 4

Completed

• Conditions: Lumbar Disc Herniation; Lumbar Spine Instability; Lumbar Spinal Stenosis; Lumbar Spondylolisthesis
• Interventions: Drug: Ropivacaine 0.75% Injectable Solution; Drug: dexamethasone 8mg

• Registration Number: NCT05871073
• Lead Sponsor: University Hospital Fattouma Bourguiba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-02-04
• Study Completion: 2023-03-05
• Study First Submitted: 2023-04-11
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-13
• Last Update Submitted: 2023-05-13
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dexamethasone 8mg	dexamethasone 8mg	Wound Infiltration for Postoperative Analgesia After Spinal Surgery
Ropivacaine 0.75% Injectable Solution	Ropivacaine 0.75% Injectable Solution	Wound Infiltration for Postoperative Analgesia After Spinal Surgery
Dexamethasone 8mg	Ropivacaine 0.75% Injectable Solution	Wound Infiltration for Postoperative Analgesia After Spinal Surgery

Primary Outcome Measures

Name	Time	Method
the time of the first analgesic demand of PCA	at 4, 6, 12, 24, and 48 hours postoperatively	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

Trial Locations

Locations (1)

Hopital Fattouma Burguiba Monastir; 🇹🇳 Monastir, Tunisia