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Patients undergoing Bariatric Surgery at the University of California Davis Medical Center will be divided into two groups, one receiving Standard of Care pain control medications vs the second group which will receive non-narcotic pain medications with rescue pain medications available if needed
Pain control after weight loss surgery is challenging due to the alteration of digestive system anatomy and limitation on using medications which can either be crushed or in liquid form for the first 10 days to 14 days after surgery. Additionally there are multiple programs in place to eliminate the use of narcotic/opioid based pain medications due their potential addictive risks.
This study compares two groups of patients whom will have Roux en Y Gastric Bypass Surgery at UC Davis Medical Center, the control group will receive standard of care pain control medications (including opioid based medications) compared to the research arm, this group will receive Gabapentinin and Tylenol for pain control after surgery with rescue pain medications available if needed.
Post surgery both groups will be managed by the Bariatric Surgery Team and will be contacted periodically as part of the standard of care to monitor pain control and usage of any rescue medications (if needed).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications. |
|
| Multi-Modal | Experimental | Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurontin | Drug | 600 mg on-call prior to surgery, post surgery 100 mg liquid q 8-12 hours post surgery with Tylenol every 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change In Post Operative Pain Intensity | Using the Wong-Baker Pain Rating Scale-0=No Pain, 2-4, Slight Pain, 6-8, Moderate Pain, 9-10, Severe Pain | 3 Days and 14 Days Post Surgery |
| Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery | OME Table is used to measure opioid use post surgery | 3 Days and 14 Days Post Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed R Ali, MD, FACS | Professor of Surgery | Principal Investigator |
| Barbara Jachniewicz, MSN, CRNFA, | Nurse Practitioner, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Health | Sacramento | California | 95817 | United States |
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Patients will receive Gabapentin and Ofirmev post surgery (dosage based on patients pre-operative weight) with on-call medications as needed including narcotic analgesia for breakthrough pain control
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Patients agreeing to participate in the study will be assigned one of two treatment arms. Neither the care team nor the patient will be masked.
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| Dilaudid Injectable Product | Drug | .5-1 mg IV Q3 hours and IV Tylenol 1000mg every 6 hours post surgery transitioning to oral pain control medications (Hycet 7.5/325mg/5 ml, 5-10 ml every 4 hours |
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| Marcaine Injectable Product | Drug | 0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups. |
|
| Oxycodone Hydrochloride | Drug | 1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control |
|
| Hycet 7.5Mg-325Mg/15Ml Solution | Drug | Dosage: 10-15ml q4h prn for pain control |
|
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| Zofran Injection | Drug | 4 mg IV for nausea control while inpatient, prn |
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| Scopolamine patch | Drug | Topical application patch for nausea control, used with/without Ativan. |
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| Ativan | Drug | 0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control |
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| Flexeril Oral Product | Drug | 5 mg orally q8h prn for muscle spasms. |
|
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| Tylenol Suspension | Drug | 1000 mg q6h PRN for pain control. |
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|
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D004091 | Hydromorphone |
| D010098 | Oxycodone |
| C514822 | oxycodone-acetaminophen |
| D006853 | Hydrocodone |
| D017294 | Ondansetron |
| D012601 | Scopolamine |
| D008140 | Lorazepam |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003061 | Codeine |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
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