Obesity, Morbid, Postoperative Nausea and Vomiting, Postoperative Pain
Conditions
Keywords
Gastric Bypass, Gabapentin, Postoperative Nausea and Vomiting, Analgesics, Opioids, Sleep Apnea, Obstructive, Respiratory Depression, Oximetry
Brief summary
The purpose of this research study is to evaluate the drug gabapentin (Neurontin®) for its ability to reduce postoperative pain, the need for morphine-like pain medication, and the severity and frequency of postoperative nausea and vomiting in laparoscopic gastric bypass surgery patients.
Detailed description
The occurrence of morbid obesity is at epidemic proportions in the United States. Laparoscopic gastric bypass is an effective means of safely facilitating patient weight loss and thereby drastically reducing the prevalence and severity of many future health complications \[1\]. However, managing morbidly obese surgical patients poses certain obstacles for anesthesiologists, including a high incidence of obstructive sleep apnea \[2\]. Laparoscopic gastric bypass, like all surgical interventions, has associated postoperative challenges including pain management and prevention/control of postoperative nausea and vomiting. To assure the highest patient satisfaction, all areas of patient comfort must be addressed. However, with pain management in morbidly obese patients, caution must be used when administering opioids, as they can have an increasing effect of respiratory depression in patients already at risk due to obstructive sleep apnea \[3\]. Gastric bypass is also associated with a significant incidence of protracted postoperative nausea and vomiting \[4\]. Therefore, regimens that address both patient safety and patient comfort are desired. Gabapentin (Neurontin) is an alkylated analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) that has been FDA approved for the treatment of seizures, headaches fibromyalgia and chronic neuropathic pain due to various etiologies \[5\]. Many randomized controlled trials have been performed with perioperative gabapentin \[6-10\]. The effect of perioperative administration of gabapentin on postoperative pain and opioid consumption has been extensively studied and several meta-analyses have been published in the last several years examining to overall findings of these studies. The general consensus is that gabapentin has anti-hyperalgesic and opioid-sparing properties and may also reduce the incidence of postoperative nausea and vomiting \[5, 11-15\]. Most research has shown that gabapentin is beneficial in the treatment of postoperative pain, but some show neither positive nor negative effects. There has been no evidence that gabapentin is detrimental or poses any risks to the postoperative patient. However, gabapentin has not been specifically studied in bariatric surgery. Therefore, the purpose of this study is to explore the hypothesis that perioperative gabapentin has anti-hyperalgesic and opioid-sparing properties, thus increase patient comfort and satisfaction by decreasing pain scores and reducing the adverse effects of opioids, such as postoperative nausea and vomiting. This is a randomized, double-blind and placebo controlled study, which will be performed in adult laparoscopic gastric bypass patients coming to surgery for morbid obesity. The major end-points of analyses are intraoperative and postoperative opioid requirements and the incidence of nausea and vomiting in the postoperative period.
Interventions
DRUGGabapentin
Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
DRUGPlacebo
Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing laparoscopic gastric bypass surgery * Age \> 18 years
Exclusion criteria
* Patients under the age of 18 years * Patients who undergo open gastric bypass * Patients with a history of chronic pain treated with pregabalin, gabapentin or opioids * Patients with a history of chronic renal disease (creatinine \> 1.3) * Patients with a history of bleeding gastric ulcer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Amount of Diluadid Given Postoperatively | 120 hours | The amount of intraoperative and postoperative opioids used will be collected and analyzed for the three different arms. |
| Number of Participants Who Experience Incidence of Postoperative Nausea. | 120 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data | 48 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Preoperative Gabapentin Liquid Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2) | 20 |
| 2 Preoperative and Postoperative Gabapentin Liquid Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2) | 21 |
| 3 Preoperative and Postoperative Placebo Liquid Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Placebo: Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2) | 21 |
| Total | 62 |
Baseline characteristics
| Characteristic | 2 Preoperative and Postoperative Gabapentin Liquid | 3 Preoperative and Postoperative Placebo Liquid | 1 Preoperative Gabapentin Liquid | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 19 Participants | 20 Participants | 59 Participants |
| Age, Continuous | 47 years | 46 years | 47 years | 47 years |
| Region of Enrollment United States | 21 participants | 21 participants | 20 participants | 62 participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 17 Participants | 51 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 20 | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 | 0 / 21 |
Outcome results
Primary
Evaluate the Amount of Diluadid Given Postoperatively
The amount of intraoperative and postoperative opioids used will be collected and analyzed for the three different arms.
Time frame: 120 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 1 Preoperative Gabapentin Liquid | Evaluate the Amount of Diluadid Given Postoperatively | 11.035 ml |
| 2 Preoperative and Postoperative Gabapentin Liquid | Evaluate the Amount of Diluadid Given Postoperatively | 8.7 ml |
| 3 Preoperative and Postoperative Placebo Liquid | Evaluate the Amount of Diluadid Given Postoperatively | 12.4 ml |
Primary
Number of Participants Who Experience Incidence of Postoperative Nausea.
Time frame: 120 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1 Preoperative Gabapentin Liquid | Number of Participants Who Experience Incidence of Postoperative Nausea. | 12 Participants |
| 2 Preoperative and Postoperative Gabapentin Liquid | Number of Participants Who Experience Incidence of Postoperative Nausea. | 11 Participants |
| 3 Preoperative and Postoperative Placebo Liquid | Number of Participants Who Experience Incidence of Postoperative Nausea. | 12 Participants |
Secondary
Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data
Time frame: 48 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 1 Preoperative Gabapentin Liquid | Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data | 93 % oxygen saturation |
| 2 Preoperative and Postoperative Gabapentin Liquid | Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data | 94 % oxygen saturation |
| 3 Preoperative and Postoperative Placebo Liquid | Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data | 95 % oxygen saturation |