Evaluation of effect of sedation on diagnostic lumbar facet joint nerve blocks
| ISRCTN | ISRCTN23482653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23482653 |
| Secondary identifying numbers | Protocol #6 |
- Submission date
- 27/09/2005
- Registration date
- 17/11/2005
- Last edited
- 13/10/2008
- 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 that sedation has no effect on the validity of diagnostic lumbar facet joint nerve blocks. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic low back pain |
| Intervention | Intravenous injection of sodium chloride solution, midazolam, or fentanyl prior to lumbar 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, or fentanyl |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 02/02/2004 |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 subjects, randomized into 3 groups with equal distribution |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/02/2004 |
| Date of final enrolment | 30/06/2004 |
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 | 01/07/2004 | Yes | No |
