A Trial of Intravenous Paracetamol vs. Placebo in Patients Receiving Radiofrequency Ablation of the Medial Branch Facet Nerve
Unknown statusNot applicableNCT02539979
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
A double blinded randomized controlled study comparing pre-procedural IV Paracetamol versus IV placebo (normal saline). The patients will be randomized to either receiving IV paracetamol or saline infusions before undergoing radiofrequency lesioning of two levels of medial branch nerves of the lumbar facets. The primary outcome will be potential differences in pain control. The secondary outcomes will be changes in quality of life (QoL) and activities of daily living (ADLs). We will also be comparing potential differences in the amounts of post-procedure pain medications taken by the patients in each wing of the study
Study details
- Official title
- A Double Blinded Randomized Control Trial of Intravenous Paracetamol vs. Placebo in Patients Receiving Radiofrequency Ablation of the Medial Branch Facet Nerve
- Conditions
- Chronic Lower Back Pain
- Lumbar Facet Syndrome
- Interventions
- Drug: Paracetamol
- Drug: Placebo - Normal Saline
- Sponsor
- Sheba Medical Center
- Start date
- 2015-08
- Primary completion
- 2016-10
- Sex
- All
- Age range
- from 18 Years to 99 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Israel
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * • Men and women. * Age of 18+ years * Weight over 50 kg * Fits criteria for procedure-- radiofrequency ablation of medial branch facet nerve Exclusion Criteria: * • Patients who are incapable of judgment and\\or to give informed consent. * Pregnant or nursing. * Under 18 years old * Allergies to Paracetamol, Lidocaine, Midazolam, Depomerol * Chronic Paracetamol use (or products with Paracetamol- e.g.- Zaldiar) 2 weeks preoperatively.\*\* * Chronic NSAID use (or products containing NSAIDS) for 2 weeks pre-operatively.\*\* * Illicit Drug use 48 hours prior to participation. * Current alcohol abuse (3 or more alcoholic drinks per day) * Severe liver disease * Severe cardiac disease * Severe renal disease * Platelet dysfunction or other bleeding disorder * Currently unstable psychiatric disorders. * Primary diagnosis of fibromyalgia * \*\*If the patient is taking chronic pain medication other than Paracetamol or NSAIDS they may continue to take them and it will be standardized and accounted for (eg.- opioids to morphine mEq).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02539979