Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cadence Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length of stay and morbidity is intimately associated with post-operative nausea and vomiting (PONV) and recovery of bowel function. Medications most commonly used to control for post-operative pain are opioid medications, whose well known adverse effects include PONV. Currently, no studied adequate alternative to opiates exists for mild-moderate pain relief without the aforementioned risks.
The primary goal for this study is to evaluate the the administration of pre- and post-operative IV acetaminophen to determine if there is in an overall decrease in the use of opioid analgesics by patient controlled analgesia (PCA) and subsequent decrease in subjective PONV leading to sooner return of bowel function, enabling progression to oral intake and decrease in post-operative length of stay.
Opioid use during the post-operative period is a highly effective means of treatment for acute pain, however not without its adverse effects including post-operative nausea, vomiting (PONV), constipation, urinary retention, sedation and respiratory depression. Such factors have been implied in the literature to contribute to prolonged post-operative length of stay, delayed return to diet, return of bowel function and increased incidence of ileus. Alternatively, non-opioids, such as acetaminophen, aspirin, NSAIDs, and selective cyclo-oxygenase-2 inhibitors, can be utilized for acute pain, either alone or in combination with opioids. In the bariatric post-surgical population, NSAIDS both oral and IV (Toradol, Ibuprofen) are not recommended due to their potential bleeding tendency, anti-inflammatory effect, and ulcerogenic effect.
The LRYGBP may be classified as a surgery type associated with mild to moderate post-operative pain. Therefore, the mode of pain relief could directly affect the length of stay. The advent of IV acetaminophen serves as a opportunity to investigate in detail the efficacy of this non-opioid medication in the management of acute pain in the immediate post-operative period without the aforementioned adverse effects as expected from traditional opiate medications. A comprehensive approach to this study includes a prospective, double-blinded, randomized controlled trial of subjects who will undergo LRYGBP and randomized to the study agent (IV acetaminophen) or placebo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV acetaminophen | Active Comparator |
| |
| IV 0.9% normal saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV acetaminophen | Drug | IV acetaminophen 1000 mg (100 mL) every 6 hours over 30 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| difference in post-operative opiate consumption (PCA) | hourly, 30 hours from first dose of study agent |
| Measure | Description | Time Frame |
|---|---|---|
| post-operative subjective pain intensity | every 2 hours, 30 hours from first dose of study agent | |
| post-operative nausea and vomiting (PONV) | every 2 hours, 30 hours from first dose of study agent |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Lee, B.Sc. | Contact | 517-505-4640 | leechr28@msu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christina Lee, B.Sc. | McLaren Regional Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLaren Regional Medical Center | Recruiting | Flint | Michigan | 48532 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10945358 | Background | Nguyen NT, Ho HS, Palmer LS, Wolfe BM. A comparison study of laparoscopic versus open gastric bypass for morbid obesity. J Am Coll Surg. 2000 Aug;191(2):149-55; discussion 155-7. doi: 10.1016/s1072-7515(00)00276-3. | |
| 11472277 | Result | Walder B, Schafer M, Henzi I, Tramer MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand. 2001 Aug;45(7):795-804. doi: 10.1034/j.1399-6576.2001.045007795.x. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 15, 2017 | |
| Reset | May 23, 2017 | |
| Release | Aug 8, 2017 | |
| Reset | Sep 8, 2017 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 15, 2017 | May 23, 2017 | |||
| Aug 8, 2017 |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D010149 | Pain, Postoperative |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| IV normal saline |
| Drug |
0.9% normal saline IV, every 6 hours over 30 hours. |
|
| time to first post-operative drug administration | up to 30 hours from first dose of study agent |
| time to return to flatus | up to 30 hours from first dose of study agent |
| acceptance of rescue medication | up to 30 hours from first dose of study agent |
| time to first request for rescue medication | up to 30 hours from first dose of study agent |
| readiness for discharge | up to 72 hours from the first dose of study agent |
| 21114616 | Result | Macario A, Royal MA. A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain. Pain Pract. 2011 May-Jun;11(3):290-6. doi: 10.1111/j.1533-2500.2010.00426.x. Epub 2010 Nov 28. |
| 21353105 | Result | Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011. |
| 15978146 | Result | Madan AK, Ternovits CA, Speck KE, Tichansky DS. Inpatient pain medication requirements after laparoscopic gastric bypass. Obes Surg. 2005 Jun-Jul;15(6):778-81. doi: 10.1381/0960892054222812. |
| Sep 8, 2017 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012817 | Signs and Symptoms, Digestive |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |