Postoperative Nausea, Postoperative Pain, Postoperative Vomiting
Conditions
Keywords
IV Acetaminophen, Laparoscopic cholecystectomy, Postoperative nausea, Postoperative vomiting
Brief summary
The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.
Detailed description
The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.
Interventions
DRUGIV Acetaminophen
Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen
DRUGStandard of Care
Standard of care pain management regimen, no IV Acetaminophen,
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject is undergoing pre-scheduled laparoscopic cholecystectomy; * American Society of Anesthesiology patient classification status I-II
Exclusion criteria
* Regular preoperative use of or opioids, * Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV. * Subjects converted to open laparoscopic cholecystectomy * Known allergy/hypersensitivity to acetaminophen * Use of opioids prior to commencement of the study (\<7 days) * Patients with chronic pain conditions or disease requiring pain control * Abnormal liver function * Known or suspected alcohol, drug or opiate abuse or dependence * Patients with a BMI of greater than 35 * Other physical, mental or medical conditions that could effect participation. * Abnormal renal function; serum creatinine\>2gm/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Nausea and Vomiting (PONV). | 4 hours plus/minus 30 minutes | Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post Discharge Nausea and Vomiting (PDNV) | Up to two days following surgery | Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge. |
| Highest Pain Intensity Score Using Numeric Rating Scale (NRS) | 4 hours plus/minus 30 minutes | Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities. |
| Patient Satisfaction on a 5 Point Likert Scale | Up to one week following surgery | Number of patients very satisfied or satisfied with pain and PONV management during hospital stay |
| Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale | 1 hour following surgery | Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Requiring Rescue Analgesia for Breakthrough Pain | 1 hour following surgery | Number of patients requiring rescue analgesia medication during first hour of PACU stay |
| Narcotic Use During PACU Stay | 4 hours plus/minus 30 minutes | Narcotic medication administered during PACU stay in morphine milligram equivalents |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Acetaminophen IV Acetaminophen administered before PACU admission
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes | 52 |
| Standard of Care Standard of care pain management regimen including opioids
Standard of Care: No IV acetaminophen | 53 |
| Total | 105 |
Baseline characteristics
| Characteristic | IV Acetaminophen | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 13 | 44.9 years STANDARD_DEVIATION 12.3 | 44.7 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment United States | 52 participants | 53 participants | 105 participants |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 52 | 23 / 53 |
| serious Total, serious adverse events | 0 / 52 | 0 / 53 |
Outcome results
Primary
Number of Participants With Postoperative Nausea and Vomiting (PONV).
Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.
Time frame: 4 hours plus/minus 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Number of Participants With Postoperative Nausea and Vomiting (PONV). | 15 Participants |
| Standard of Care | Number of Participants With Postoperative Nausea and Vomiting (PONV). | 17 Participants |
p-value: >0.05Chi-squared
Secondary
Highest Pain Intensity Score Using Numeric Rating Scale (NRS)
Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.
Time frame: 4 hours plus/minus 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Acetaminophen | Highest Pain Intensity Score Using Numeric Rating Scale (NRS) | 6 Units on a numerical rating scale |
| Standard of Care | Highest Pain Intensity Score Using Numeric Rating Scale (NRS) | 6 Units on a numerical rating scale |
Secondary
Number of Participants With Post Discharge Nausea and Vomiting (PDNV)
Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge.
Time frame: Up to two days following surgery
Population: Post-discharge follow up group. Patients not included in analysis were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Number of Participants With Post Discharge Nausea and Vomiting (PDNV) | 4 Participants |
| Standard of Care | Number of Participants With Post Discharge Nausea and Vomiting (PDNV) | 10 Participants |
Secondary
Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale
Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities
Time frame: 1 hour following surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Acetaminophen | Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale | 3 Units on a numerical rating scale |
| Standard of Care | Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale | 3 Units on a numerical rating scale |
Secondary
Patient Satisfaction on a 5 Point Likert Scale
Number of patients very satisfied or satisfied with pain and PONV management during hospital stay
Time frame: Up to one week following surgery
Population: Post-discharge follow up group. Patients not included in analysis were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Patient Satisfaction on a 5 Point Likert Scale | 38 Participants |
| Standard of Care | Patient Satisfaction on a 5 Point Likert Scale | 35 Participants |
Other Pre-specified
Narcotic Use During PACU Stay
Narcotic medication administered during PACU stay in morphine milligram equivalents
Time frame: 4 hours plus/minus 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IV Acetaminophen | Narcotic Use During PACU Stay | 13.3 Morphine milligram equivalents |
| Standard of Care | Narcotic Use During PACU Stay | 16.8 Morphine milligram equivalents |
Other Pre-specified
Number of Patients Requiring Rescue Analgesia for Breakthrough Pain
Number of patients requiring rescue analgesia medication during first hour of PACU stay
Time frame: 1 hour following surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Number of Patients Requiring Rescue Analgesia for Breakthrough Pain | 28 Participants |
| Standard of Care | Number of Patients Requiring Rescue Analgesia for Breakthrough Pain | 20 Participants |