Chronic low back pain Musculoskeletal Diseases Back pain
Conditions
Interventions
Intravenous injection of sodium chloride solution, midazolam, or fentanyl prior to lumbar facet joint nerve blocks under fluoroscopy.
Sponsors
Ambulatory Surgery Center and Pain Management Center of Paducah (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects were between 18 and 90 years of age 2. Subjects with a history of chronic, function limiting, low back pain of at least 6 months duration 3. Subjects able to give voluntary, written informed consent to participate in the investigation 4. Subjects who, in the opinion of the investigator, are able to understand the investigation and/or cooperate with the investigational procedures 5. Patients who have undergone diagnostic facet joint blocks and the diagnosis of lumbar facet joint pain has been previously confirmed
Exclusion criteria
Exclusion criteria: 1. Patients without lumbar facet joint pain 2. Patients with uncontrolled major depression or uncontrolled psychiatric disorders 3. Pregnant or lactating women 4. Patients with multiple complaints involving multiple other problems which have overlapping pain complaints 5. Patients unable to achieve proper positioning or unable to understand informed consent and protocol 6. Patients with a history of adverse reaction to either midazolam or fentanyl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For a small proportion of patients with chronic low back pain, the administration of sedation with midazolam or fentanyl can be a confounding factor in the diagnosis of lumbar facet joint pain. The study shows that an intravenous preoperative sedative dose of a narcotic such as fentanyl or an anxiolytic such as midazolam is no more likely to cause a small proportion of patients to report false positive pain relief with active motion testing than sodium chloride placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| The study suggests that prudent administration of midazolam or fentanyl to patients who are not relaxed may not have any significant adverse effect on the diagnostic validity of controlled comparative local anesthetic blocks. | — |
Countries
United States of America
Outcome results
None listed