Osteoarthritis
Conditions
Keywords
acetaminophen, timing, arthroplasty
Brief summary
The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the pre-closure group will receive the first dose administered upon onset of skin closure, 2) the preemptive group will receive the first dose administered within 60 minutes prior to incision. Both groups will receive subsequent doses every 6 hours x 24 hours.
Detailed description
The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the closure group will receive the first dose of one gram of intravenous acetaminophen administered upon onset of skin closure, 2) the preemptive group will receive the first dose of one gram of intravenous acetaminophen administered within 60 minutes prior to incision. Both groups will receive subsequent doses of one gram of intravenous acetaminophen every 6 hours x 24 hours. The maximum dose in a 24 hour period will not exceed 4 grams according to FDA recommendations.
Interventions
DRUGAcetaminophen
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients 30-75 years of age weighing ≥55 kg scheduled for elective total hip arthroplasty performed under general anesthesia will be included. As determined by the anesthesia team assigned to the case, eligible patients will also be assigned ASA physical status of I, II, or III and deemed capable of reporting their perceived pain using numeric pain scales and capable of operating a patient controlled anesthesia (PCA) device.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Postoperative Pain Scores | preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug | To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Medication Consumption Rates | Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug | Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Length of Stay (LOS) | Baseline to discharge (1-4 days) | To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preemptive Group The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.
Acetaminophen | 57 |
| Closure Group The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
Acetaminophen | 56 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Protocol Violation | 4 | 7 |
| Overall Study | record could not be located | 1 | 0 |
Baseline characteristics
| Characteristic | Preemptive Group | Closure Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 56 Participants | 113 Participants |
| Age, Continuous | 60.5 years | 61.7 years | 61.1 years |
| Region of Enrollment United States | 57 participants | 56 participants | 113 participants |
| Sex: Female, Male Female | 32 Participants | 18 Participants | 50 Participants |
| Sex: Female, Male Male | 25 Participants | 38 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 1 / 56 |
| serious Total, serious adverse events | 0 / 57 | 0 / 56 |
Outcome results
Primary
Changes in Postoperative Pain Scores
To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain
Time frame: preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preemptive Group | Changes in Postoperative Pain Scores | preoperatively (baseline) | 2.7 units on a scale | Standard Deviation 1.41 |
| Preemptive Group | Changes in Postoperative Pain Scores | PACU arrival (2-3 hour) | 0.9 units on a scale | Standard Deviation 2.3 |
| Preemptive Group | Changes in Postoperative Pain Scores | 6 hrs post study drug | 2.6 units on a scale | Standard Deviation 2.75 |
| Preemptive Group | Changes in Postoperative Pain Scores | 12 hrs post study drug | 2.5 units on a scale | Standard Deviation 2.69 |
| Preemptive Group | Changes in Postoperative Pain Scores | 18 hrs post study drug | 2.7 units on a scale | Standard Deviation 2.45 |
| Preemptive Group | Changes in Postoperative Pain Scores | 24 hrs post study drug | 3.0 units on a scale | Standard Deviation 2.53 |
| Closure Group | Changes in Postoperative Pain Scores | 18 hrs post study drug | 2.6 units on a scale | Standard Deviation 2.28 |
| Closure Group | Changes in Postoperative Pain Scores | preoperatively (baseline) | 2.5 units on a scale | Standard Deviation 2.69 |
| Closure Group | Changes in Postoperative Pain Scores | 12 hrs post study drug | 2.3 units on a scale | Standard Deviation 2.05 |
| Closure Group | Changes in Postoperative Pain Scores | PACU arrival (2-3 hour) | 1.5 units on a scale | Standard Deviation 3.1 |
| Closure Group | Changes in Postoperative Pain Scores | 24 hrs post study drug | 2.9 units on a scale | Standard Deviation 2.44 |
| Closure Group | Changes in Postoperative Pain Scores | 6 hrs post study drug | 2.6 units on a scale | Standard Deviation 2.21 |
Secondary
Pain Medication Consumption Rates
Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.
Time frame: Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preemptive Group | Pain Medication Consumption Rates | 50 participants |
| Closure Group | Pain Medication Consumption Rates | 42 participants |
Other Pre-specified
Average Length of Stay (LOS)
To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.
Time frame: Baseline to discharge (1-4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preemptive Group | Average Length of Stay (LOS) | 2.5 days | Standard Deviation 0.5 |
| Closure Group | Average Length of Stay (LOS) | 2.0 days | Standard Deviation 0 |