Evaluation of effect of sedation on diagnostic cervical facet joint nerve blocks
| ISRCTN | ISRCTN52746887 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52746887 |
| Secondary identifying numbers | Protocol #5 |
- Submission date
- 27/09/2005
- Registration date
- 17/11/2005
- Last edited
- 02/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Laxmaiah Manchikanti
Scientific
Scientific
2831 Lone Oak Road
Paducah, KY
42003
United States of America
| Phone | +1 270 554 8373 |
|---|---|
| drm@asipp.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To demonstrate sedation has no effect on the validity of diagnostic cervical facet joint nerve blocks. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic neck pain |
| Intervention | Intravenous injection of sodium chloride solution, midazolam, or fentanyl prior to cervical facet joint nerve blocks under fluoroscopy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sodium chloride solution, midazolam and fentanyl |
| Primary outcome measure | 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 | 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. |
| Overall study start date | 02/02/2004 |
| Completion date | 30/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 patients, randomized into 3 groups with equal distribution. |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 02/02/2004 |
| Date of final enrolment | 30/04/2004 |
Locations
Countries of recruitment
- United States of America
Study participating centre
2831 Lone Oak Road
Paducah, KY
42003
United States of America
42003
United States of America
Sponsor information
Ambulatory Surgery Center and Pain Management Center of Paducah (USA)
Hospital/treatment centre
Hospital/treatment centre
2831 Lone Oak Road
Paducah, KY
42003
United States of America
| Phone | +1 270 554 8373 |
|---|---|
| drm@asipp.org | |
| Website | http://www.thepainmd.com |
Funders
Funder type
Hospital/treatment centre
Ambulatory Surgery Center and Pain Management Center of Paducah (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2004 | Yes | No |
