Obesity, Pain
Conditions
Keywords
Pain Management
Brief summary
Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.
Interventions
DRUGAcetaminophen
Intravenous Acetaminophen 1,000 mg IV
DRUGPlacebo
Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl)
Sponsors
Trinity Health Of New England
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Morbidly Obese and body mass index (BMI) of 35 * Between ages 20-17 * Candidates for Laparoscopic Bariatric Surgery
Exclusion criteria
* know hypersensitivity to acetaminophen or opioids * impairment in liver function * renal dysfunction * mental retardation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours | baseline and 24 hours | The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours | baseline and 24 hours | The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline) |
| Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent. | 24 hours after baseline | The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Active Drug Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Acetaminophen: Intravenous Acetaminophen 1,000 mg IV | 16 |
| Arm 2 - Placebo Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Placebo: Placebo - IV administration 0.9% 100 ml NaCl | 18 |
| Total | 34 |
Baseline characteristics
| Characteristic | Total | Arm 1 - Active Drug | Arm 2 - Placebo |
|---|---|---|---|
| Age, Customized 20 to 70 Years | 34 Participants | 16 Participants | 18 Participants |
| Sex: Female, Male Female | 22 Participants | 11 Participants | 11 Participants |
| Sex: Female, Male Male | 12 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 18 |
| serious Total, serious adverse events | 0 / 16 | 1 / 18 |
Outcome results
Primary
Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours
The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)
Time frame: baseline and 24 hours
Population: Study was terminated - data were determined to be unusable by IRB due to consent issues.
Secondary
Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours
The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline)
Time frame: baseline and 24 hours
Population: Study was terminated - data were determined to be unusable by IRB due to consent issues.
Secondary
Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent.
The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline.
Time frame: 24 hours after baseline
Population: Study was terminated - data were determined to be unusable by IRB due to consent issues.