Evaluation of effect of sedation on diagnostic cervical facet joint nerve blocks
- Conditions
- Chronic neck painMusculoskeletal DiseasesNeck pain
- Registration Number
- ISRCTN52746887
- Lead Sponsor
- Ambulatory Surgery Center and Pain Management Center of Paducah (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 180
1. Subjects were between 18 and 90 years of age
2. Subjects had a history of chronic, function limiting, neck pain of at least 6 months duration
3. Subjects were 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. Subjects who had undergone diagnostic facet joint blocks and the diagnosis of cervical facet joint pain has been confirmed previously
1. Subjects without cervical facet joint pain
2. Subjects with uncontrollable major depression or uncontrolled psychiatric disorders
3. Pregnant or lactating women
4. Subjects with multiple complaints involving multiple other problems with overlapping pain complaints
5. Subjects unable to achieve appropriate positioning and inability to understand informed consent and protocol
6. Subjects with a history of adverse reaction to either midazolam or fentanyl
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The administration of sedation with midazolam or fentanyl could be a confounding factor in the diagnosis of cervical facet joint pain in patients with chronic neck pain. However, if =80% pain relief with the ability to perform prior painful movements is used as the diagnostic standard, the effect of sedation on validity may be extremely low. In contrast, a significant number of patients may present as false-positives if =50% pain relief with ability to perform prior painful movements is used as the diagnostic criteria.
- Secondary Outcome Measures
Name Time Method Prudent administration of midazolam only to patients who are not relaxed may not have significant adverse effect on the diagnostic validity of controlled comparative local anesthetic blocks. On the other hand, fentanyl could confound the diagnosis with false-positive results in a significant proportion of patients.