A Trial of Intravenous Paracetamol vs. Placebo in Patients Receiving Radiofrequency Ablation of the Medial Branch Facet Nerve

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Acetaminophen

Criteria

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).