Inguinal Hernia
Conditions
Keywords
Acetaminophen, Tylenol, Intravenous versus oral
Brief summary
There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.
Detailed description
In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.
Interventions
DRUGAcetaminophen IV Soln
1000mg of IV acetaminophen
oral acetaminophen 975mg pills
DRUGPlacebo Pills
placebo match to acetaminophen
DRUGSaline
Intravenous saline
Sponsors
Yan Lai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA scores I-III * Ambulatory surgery patients * Ages 18-75 * Surgeries requiring general anesthesia for hernia surgery
Exclusion criteria
* Patients with contraindications to acetaminophen (history of end organ liver dysfunction) * Known allergy to acetaminophen * Emergency surgery * Patients who were not fasted * Patients who cannot tolerate PO * Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen * Pregnancy * Weight less than 50kg * Chronic daily narcotic use * Patients who's anesthetic plan requires regional anesthesia * Patient refusal to participate or do not have capacity to provide consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PACU Visual Analogue Pain Scores | baseline, 1 hour, and Day 1 discharge | Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain. |
| Total MME Intraoperatively | Day 1 | Total Morphine Milligram Equivalent (MME) use intraoperatively |
| Total Narcotic Use in PACU. | Day 1 | Total narcotic use in PACU expressed in total morphine milligram equivalents (MME) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PACU Length of Stay | up to 24 hours after PACU arrival | Time in PACU |
| Patient Reported Total Narcotic Use Post-discharge | average 7 days | home opiod use |
| Patient Satisfaction. | 7 days post surgery | Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction |
Countries
United States
Participant flow
Recruitment details
Participants presenting for laparoscopic hernia repair under general anesthesia in an ambulatory setting were recruited from July 2017 to December 2018. First enrollment in Dec 2017.
Participants by arm
| Arm | Count |
|---|---|
| Oral Acetaminophen Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively. | 56 |
| Acetaminophen IV Soln Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively | 44 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Oral Acetaminophen | Acetaminophen IV Soln | Total |
|---|---|---|---|
| Age, Continuous | 53.93 years STANDARD_DEVIATION 13.37 | 52.52 years STANDARD_DEVIATION 15.1 | 53.31 years STANDARD_DEVIATION 14.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 23 Participants | 20 Participants | 43 Participants |
| Sex: Female, Male Male | 33 Participants | 24 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 44 |
| other Total, other adverse events | 0 / 56 | 0 / 44 |
| serious Total, serious adverse events | 0 / 56 | 0 / 44 |
Outcome results
Primary
PACU Visual Analogue Pain Scores
Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.
Time frame: baseline, 1 hour, and Day 1 discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Acetaminophen | PACU Visual Analogue Pain Scores | 1 hour | 2.88 score on a scale | Standard Deviation 2.74 |
| Oral Acetaminophen | PACU Visual Analogue Pain Scores | Discharge from PACU, up to 2.5 hours | 1.45 score on a scale | Standard Deviation 1.51 |
| Oral Acetaminophen | PACU Visual Analogue Pain Scores | 6 hour post op | 3.82 score on a scale | Standard Deviation 2.28 |
| Oral Acetaminophen | PACU Visual Analogue Pain Scores | 24 hour post op | 3.64 score on a scale | Standard Deviation 2.26 |
| Oral Acetaminophen | PACU Visual Analogue Pain Scores | Baseline | 2.13 score on a scale | Standard Deviation 2.72 |
| Acetaminophen IV Soln | PACU Visual Analogue Pain Scores | Baseline | 1.52 score on a scale | Standard Deviation 2.44 |
| Acetaminophen IV Soln | PACU Visual Analogue Pain Scores | 24 hour post op | 4.16 score on a scale | Standard Deviation 1.83 |
| Acetaminophen IV Soln | PACU Visual Analogue Pain Scores | Discharge from PACU, up to 2.5 hours | 1.59 score on a scale | Standard Deviation 1.44 |
| Acetaminophen IV Soln | PACU Visual Analogue Pain Scores | 1 hour | 2.41 score on a scale | Standard Deviation 2.21 |
| Acetaminophen IV Soln | PACU Visual Analogue Pain Scores | 6 hour post op | 4.27 score on a scale | Standard Deviation 1.74 |
Primary
Total MME Intraoperatively
Total Morphine Milligram Equivalent (MME) use intraoperatively
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Acetaminophen | Total MME Intraoperatively | 63.75 MME | Standard Deviation 21.33 |
| Acetaminophen IV Soln | Total MME Intraoperatively | 57.24 MME | Standard Deviation 29.2 |
Primary
Total Narcotic Use in PACU.
Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Acetaminophen | Total Narcotic Use in PACU. | 11.33 MME | Standard Deviation 17.1 |
| Acetaminophen IV Soln | Total Narcotic Use in PACU. | 9.83 MME | Standard Deviation 11.99 |
Secondary
PACU Length of Stay
Time in PACU
Time frame: up to 24 hours after PACU arrival
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Acetaminophen | PACU Length of Stay | 82.93 minutes | Standard Deviation 55.79 |
| Acetaminophen IV Soln | PACU Length of Stay | 64.05 minutes | Standard Deviation 33.13 |
Secondary
Patient Reported Total Narcotic Use Post-discharge
home opiod use
Time frame: average 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Acetaminophen | Patient Reported Total Narcotic Use Post-discharge | 14.06 MME | Standard Deviation 14.02 |
| Acetaminophen IV Soln | Patient Reported Total Narcotic Use Post-discharge | 17.56 MME | Standard Deviation 17.42 |
Secondary
Patient Satisfaction.
Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction
Time frame: 7 days post surgery
Population: one missing survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Acetaminophen | Patient Satisfaction. | 5.05 score on a scale | Standard Deviation 2.18 |
| Acetaminophen IV Soln | Patient Satisfaction. | 6.20 score on a scale | Standard Deviation 3.01 |