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This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.
The purpose of this study is to assess pain response to EUS guided celiac plexus block treatment compared to no treatment. The Visual Analog Scale (VAS) is the primary measure. Secondary aims include the comparison of quality of life scores, need for narcotics, to assess the effect of EUS-CPB on overall mental state using the Beck's Depression Index, and to assess the effect of EUS-CBP on health care utilization and on employment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celiac Plexus Block | Experimental | Celiac Plexus Block will be administered following EUS |
|
| Sham | Sham Comparator | A celiac plexus block will not be administered for pain management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celiac Plexus Block | Procedure | Patients will receive celiac plexus block during endoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Response Over a 6 Month Period of Time Using the VAS Score | Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain. | baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Quality of Life Score Between Each Group at 6 Months | The American Chronic Pain Association, Quality of Life Score will be used. This scoring ranges from 0 (Stay in bed all day Feel hopeless and helpless about life - non-functioning) to 10 (Go to work/volunteer each day Normal daily activities each day Have a social life outside of work Take an active part in family life - normal life). | 6 months post baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles M Wilcox, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Celiac Plexus Block | Celiac Plexus Block will be administered following EUS Celiac Plexus Block |
| FG001 | Sham | A celiac plexus block will not be administered for pain management Sham |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Celiac Plexus Block | Celiac Plexus Block will be administered following EUS Celiac Plexus Block |
| BG001 | Sham | A celiac plexus block will not be administered for pain management Sham |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Response Over a 6 Month Period of Time Using the VAS Score | Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain. | All subjects were lost to follow up by 6 months; the primary endpoint was not collected for any subject | Posted | baseline to 6 months |
|
24-48 hour, 2 week, 6 month, 12 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Celiac Plexus Block | Celiac Plexus Block will be administered following EUS Celiac Plexus Block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaypal Ramesh | University of Alabama at Birmingham | 205-975-9564 | jramesh@uab.edu |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham | Procedure | Patients will not receive celiac plexus block during endoscopy. |
|
| Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline | the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted. | baseline to 6 months |
| Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months. | The Beck's Depression scale was used to indicate subject's depression: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. | baseline to 6 months |
| Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure | The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group | baseline to 6 months |
| % of Subjects in Each Group That Are Employed at 6 Months Post Procedure. | Subjects will be asked about employment at 6 months post procedure | baseline to 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Mean Quality of Life Score Between Each Group at 6 Months | The American Chronic Pain Association, Quality of Life Score will be used. This scoring ranges from 0 (Stay in bed all day Feel hopeless and helpless about life - non-functioning) to 10 (Go to work/volunteer each day Normal daily activities each day Have a social life outside of work Take an active part in family life - normal life). | All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject | Posted | 6 months post baseline |
|
|
| Secondary | Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline | the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted. | All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject | Posted | baseline to 6 months |
|
|
| Secondary | Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months. | The Beck's Depression scale was used to indicate subject's depression: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. | All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject | Posted | baseline to 6 months |
|
|
| Secondary | Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure | The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group | All subjects were lost to follow up by 6 months; since everyone dropped out at different times before the 6 month point, the data would not be evaluable. | Posted | baseline to 6 months |
|
|
| Secondary | % of Subjects in Each Group That Are Employed at 6 Months Post Procedure. | Subjects will be asked about employment at 6 months post procedure | All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject | Posted | baseline to 6 months |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Sham | A celiac plexus block will not be administered for pain management Sham | 0 | 1 | 0 | 1 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |