Postoperative Pain
Conditions
Brief summary
The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.
Interventions
DRUGExparel
In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.
PROCEDURETAP Block
no intervention will be done to this arm.
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients over the age of 18 years w 2. Elective laparoscopic colorectal resection.
Exclusion criteria
1. Patients under 18 years. 2. Patients unable to provide informed consent 3. Patients undergoing emergency surgery. 4. Pregnant women 5. Severe liver or kidney disease (GFR 15-29 ml/min)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | participants will be followed for the duration of hospital stay, an expected average of 4 days | Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Narcotic Use | participants will be followed for the duration of hospital stay, an expected average of 4 days | Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications. | participants will be followed for the duration of hospital stay, and 30 days after discharge. | Any postoperative complications within 30 days of procedure, including death will be recorded. |
| Length of Hospital Stay. | participants will be followed for the duration of hospital stay, an expected average of 4 days | Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAP Block Patient received TAP block | 25 |
| no TAP Block patient did not received TAP block | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | no TAP Block | TAP Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 13 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 12 Participants | 26 Participants |
| Age, Continuous | 65.6 years STANDARD_DEVIATION 12.5 | 62.4 years STANDARD_DEVIATION 13.9 | 64 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 11 Participants | 14 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 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Postoperative Pain Score
Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Postoperative Pain Score | 4.2 units on a scale |
| no TAP Block | Postoperative Pain Score | 4.5 units on a scale |
Secondary
Postoperative Narcotic Use
Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Postoperative Narcotic Use | 85 mg |
| no TAP Block | Postoperative Narcotic Use | 110 mg |
Other Pre-specified
Length of Hospital Stay.
Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Length of Hospital Stay. | 4 days |
| no TAP Block | Length of Hospital Stay. | 4 days |
Other Pre-specified
Postoperative Complications.
Any postoperative complications within 30 days of procedure, including death will be recorded.
Time frame: participants will be followed for the duration of hospital stay, and 30 days after discharge.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAP Block | Postoperative Complications. | 7 participants |
| no TAP Block | Postoperative Complications. | 9 participants |