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NCT04447950
A Randomized, Double Blind, Placebo Controlled Evaluation Trial of the Benefit in Quadratus Lumborum Block as a Postoperative Analgesic Technique for a Lumbar Spine Decompression and Fusion Surgery
NA trial testing Type 2/posterior Quadratus Lumborum block in Spinal Stenosis Lumbar in 100 participants. Status unknown.
1 May 2021
Quick facts
| Lead sponsor | Assuta Medical Center |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 June 2020 |
| Primary completion | 1 May 2021 |
| Estimated completion | 1 August 2021 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Type 2/posterior Quadratus Lumborum block
- Placebo block with Saline
Conditions studied
- Spinal Stenosis Lumbar — all drugs for Spinal Stenosis Lumbar →
- Spondylolisthesis — all drugs for Spondylolisthesis →
- Fusion of Spine, Lumbar Region — all drugs for Fusion of Spine, Lumbar Region →
- Degeneration Spine — all drugs for Degeneration Spine →
Sponsor
Assuta Medical Center
Who can join
Adults 18 to 80, any sex, with Spinal Stenosis Lumbar or Spondylolisthesis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in the use of post-operative narcotics
Time frame: Will be reported for each postoperative day during the inpatient stay of the patient to a maximum of 7 days.
Difference in MME (morphine milligrams equivalent) of inpatient narcotics consumption.
Sponsor's own description
Lumbar spinal decompression and fusion is a commonly performed procedure fro neural impingement and back pain from a variety of pathologies. The importance of pain control in the postoperative period for spinal surgery has been discussed and proven extensively, with both immediate and delayed reduction in complications and improved clinical results. Quadratus lumborum (QL) block was introduced in 2007 and is performed under ultrasound guidance for perioperative pain management in various surgeries.However, the plane for a posterior QL block can be easily reached during open midline spinal surgery. The investigators hypothesize that the posterior QL block is an effective analgesic tool for lumbar laminectomy surgery, because in lumbar laminectomy the quadratus lumborum is already exposed and is in direct visual contact. For that reason it is imperative to test the benefits of this procedure. This is a double blinded randomized control study to assess the results of intra-operative QL block performed for lumbar decompression and fusion.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04447950
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Assuta Medical Center trials
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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 NCT04447950 (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 Assuta Medical Center
- Last refreshed: 24 June 2020
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/NCT04447950.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing