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Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly obese patients undergoing laparoscopic gastric bypass surgery.
Pregabalin is a popular adjunct for relieving neuropathic pain in diabetics. There have been multiple studies evaluating its use in pre and post-operative pain control in various surgeries. Post-operative pain control is a challenging problem in bariatric patients due to the high doses of narcotic required, related to the high body mass, and the danger of concomitant respiratory depression. In the obese patient, the goal of postoperative pain management is provision of comfort, early mobilization and improved respiratory function, without causing inadequate pain control, respiratory compromise or increased nausea.
Methods: A Randomized Controlled Trial, whereby patients undergoing Laparoscopic Roux-en-Y gastric bypass will be administered a single pre-operative dose of Pregabalin or a placebo. We plan to follow their immediate post-operative course in the hospital, with regard to the following primary endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Experimental | Single, 300 mg pre-operative oral dose of Pregabalin. |
|
| Sugar Pill | Placebo Comparator | Single, placebo pre-operative dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | One 300 mg oral dose of Pregabalin given before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Medication Requirements | Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Length of stay in days after surgical procedure | Days in hospital following surgical procedure, up to 5 days |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Halpin, MD | Legacy Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Legacy Good Samaritan Medical Center | Portland | Oregon | 97210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Single, 300 mg pre-operative oral dose of Pregabalin. Pregabalin: One 300 mg oral dose of Pregabalin given before surgery. |
| FG001 | Sugar Pill | Single, placebo pre-operative dose. Placebo (for Pregabalin): One oral dose of placebo given before surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Single, 300 mg pre-operative oral dose of Pregabalin. Pregabalin: One 300 mg oral dose of Pregabalin given before surgery. |
| BG001 | Sugar Pill | Single, placebo pre-operative dose. Placebo (for Pregabalin): One oral dose of placebo given before surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Post-operative Pain Medication Requirements | Posted | Mean | Standard Deviation | MME | Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2. |
|
|
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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 | Pregabalin | Single, 300 mg pre-operative oral dose of Pregabalin. Pregabalin: One 300 mg oral dose of Pregabalin given before surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Valerie Halpin | Legacy Weight and Diabetes Institute | 503-413-7557 | vhalpin@lhs.org |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000073893 | Sugars |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo (for Pregabalin) | Drug | One oral dose of placebo given before surgery. |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Length of Stay | Length of stay in days after surgical procedure | Posted | Mean | Standard Deviation | Days | Days in hospital following surgical procedure, up to 5 days |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Sugar Pill | Single, placebo pre-operative dose. Placebo (for Pregabalin): One oral dose of placebo given before surgery. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |