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

NCT02539979 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-04-14

No results posted yet for this study

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

Conditions

  • Chronic Lower Back Pain
  • Lumbar Facet Syndrome

Interventions

DRUG

Paracetamol

DRUG

Placebo - Normal Saline

Normal Saline 100cc

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-10-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02539979 on ClinicalTrials.gov