Last reviewed · How we verify
NCT04411329
Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery
NA trial testing Bupivacaine in Caudal Analgesia for Lumosacral Spine Surgeries in 60 participants. Completed in 6 May 2021.
6 May 2021
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 6 June 2020 |
| Primary completion | 6 May 2021 |
| Estimated completion | 6 May 2021 |
| Sites | 2 locations across Egypt |
Drugs / interventions tested
- Bupivacaine (BUPIVACAINE) — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
- Dexmedetomidine (dexmedetomidine) — full drug profile →
- Hyalouridinase — full drug profile →
Conditions studied
- Caudal Analgesia for Lumosacral Spine Surgeries — all drugs for Caudal Analgesia for Lumosacral Spine Surgeries →
Sponsor
Ain Shams University
Who can join
Adults 18 to 65, any sex, with Caudal Analgesia for Lumosacral Spine Surgeries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Lumbosacral spine surgeries are accompanied with severe postoperative pain which has a negative effect on patients' recovery. Preemptive analgesia before lumbosacral spine surgeries should be implemented to prevent CNS plasticity and to provide effective pain relief. The most common way to provide pain management after spine surgery is the intravenous analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain relief. The most common way to provide pain management after spine surgery is the intravenous analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain relief. acting drugs last from 4-8 hours,But this can be prolonged by adding non opioid adjuvants like steroid( dexamethazone,betamethasone), alpha2 agonists (clonidine, dexmedetomidine), or their combination. This study will compare adding different non opioid adjuvants to bupivacaine in caudal epidural for preventive analgesia in lumbosacral spine surgery which can be a part of multimodal analgesia protocol. .
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 NCT04411329
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bupivacaine
Trials testing the same drug.
- NCT05785377 — Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia · NA · not yet recruiting
- NCT07467356 — Anterior Iliopsoas Space Block Versus PENG Block on Ease of Positioning for Spinal Anathesia in Patients Undergoing Hip · Phase 3 · recruiting
- NCT07465185 — Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery · Phase 2 · recruiting
- NCT07430085 — Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA · Phase 4 · not yet recruiting
- NCT07146685 — Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study · Phase 4 · not yet recruiting
Other Ain Shams University trials
Trials by the same sponsor.
- NCT07435493 — Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstru · NA · not yet recruiting
- NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
- NCT07531030 — Posterior Pericapsular Deep Gluteal Block Combined With Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blo · NA · not yet recruiting
- NCT06839027 — Arterial to Central co2gap in Relation to Outcome After Cardiopulmonary Bypass · not yet recruiting
- NCT07516535 — DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones · NA · not yet recruiting
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 NCT04411329 (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 Ain Shams University
- Last refreshed: 19 May 2021
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/NCT04411329.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing