Last reviewed · How we verify
NCT05871073
Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery
Phase 4 trial testing Ropivacaine 0.75% Injectable Solution in Lumbar Spinal Stenosis in 60 participants. Completed in 5 March 2023.
4 February 2023
Quick facts
| Lead sponsor | University Hospital Fattouma Bourguiba |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 January 2023 |
| Primary completion | 4 February 2023 |
| Estimated completion | 5 March 2023 |
| Sites | 1 location across Tunisia |
Drugs / interventions tested
- Ropivacaine 0.75% Injectable Solution — full drug profile →
- dexamethasone 8mg — full drug profile →
Conditions studied
- Lumbar Spinal Stenosis — all drugs for Lumbar Spinal Stenosis →
- Lumbar Disc Herniation — all drugs for Lumbar Disc Herniation →
- Lumbar Spondylolisthesis — all drugs for Lumbar Spondylolisthesis →
- Lumbar Spine Instability — all drugs for Lumbar Spine Instability →
Sponsor
University Hospital Fattouma Bourguiba
Who can join
Adults 18 to 90, any sex, with Lumbar Spinal Stenosis or Lumbar Disc Herniation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05871073
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ropivacaine 0.75% Injectable Solution
Trials testing the same drug.
- NCT06381622 — Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block · Phase 3 · completed
- NCT06376058 — Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section · NA · recruiting
- NCT05442411 — Regional Scalp Block Versus IV Parecoxib for Post-operative Cranioplasty Surgery Pain: A Comparison of Pain Score. · Phase 1 · completed
- NCT04726280 — Respiratory Impact of LA Volume After IS Block · Phase 4 · completed
- NCT05807945 — "Comparison of Intra-articular of 0.2% Ropivacaine vs. 0.75% Ropivacaine in Postoperative of Knee Arthroscopy" · Phase 4 · completed
Other recruiting trials for Lumbar Spinal Stenosis
Currently open trials in the same condition.
- NCT07489001 — Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery · recruiting
- NCT07233798 — Presence of Dural Pulsation in Patients Diagnosed With Lumbar Spinal Stenosis · recruiting
- NCT07281625 — Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis · EARLY_PHASE1 · recruiting
- NCT07001982 — Lumbar Spinal Stenosis and Central Sensitization · recruiting
- NCT06959355 — Frailty and Associated Factors in Lumbar Spinal Stenosis · recruiting
Other University Hospital Fattouma Bourguiba trials
Trials by the same sponsor.
- NCT06488794 — Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia · Phase 2, PHASE3 · not yet recruiting
- NCT05314673 — Preoperative Bevacizumab Injection in Primary Pterygium in Tunisian Patients · Phase 4 · completed
- NCT03851692 — Intravenous Cannulation In Children During Sevoflurane Induction · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05871073 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Fattouma Bourguiba
- Last refreshed: 23 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05871073.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing