Opioid Use, Pain, Postoperative, Colectomy, Colorectal Surgery
Conditions
Keywords
Bupivacaine, Exparel, TAP Block, Opioids, Narcotics, ERAS
Brief summary
The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.
Detailed description
Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects. Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively). In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.
Interventions
DRUGBupivacaine
Abdominal injection of bupivacaine into fascial layer.
Abdominal injection of bupivacaine liposome into fascial layer.
Sponsors
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant and the floor nursing staff recording pain scores will be blinded to the assigned intervention.
Intervention model description
Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery
Exclusion criteria
* Allergic to local anesthetics * Unable to provide consent * Pregnant * On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study) * Undergoing emergent operations * Undergoing loop ileostomy reversal * Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Postoperative Opioid Consumption | up to postoperative day 3 at 1 pm | Daily overall opioid use recorded as morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Patient Mobilization | From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery). | Number of days from day of surgery until patient mobilization |
| Time to Return of Bowel Function | From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery). | Number of days from time of surgery until return of bowel function |
| Time to Clear Liquid Diet | From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery). | Number of days from time of surgery until patient tolerates clear liquid diet |
| Time to Low Fiber Diet | From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery). | Number of days from day of surgery until patient tolerates low fiber diet |
| Length of Stay | Date of surgery to date of discharge (usually up to 4 days after surgery). | Total postoperative hospital stay in days |
| Pain Score | Approximately every 6 hours through postoperative day 3 by 1 pm | Recorded on a scale of 0 (No pain) to 10 (Worst possible pain) |
| Complications | Within 30 days of surgery | Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery |
| Readmissions | Within 30 days of hospital discharge | Patient readmitted to hospital after discharge |
| Mortality | Within 30 days of surgery | Patient death after surgery |
| Hospitalization Costs | From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery). | Total hospitalization costs per patient per this surgical encounter |
| In-hospital Antiemetic Use | Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery). | Amount of ondansetron patient required postoperatively during hospital stay, in milligrams |
Countries
United States
Participant flow
Recruitment details
Patients were approached for consent in the hospital postoperatively to request the use of their data for research purposes.
Participants by arm
| Arm | Count |
|---|---|
| Standard Bupivacaine Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.
Bupivacaine: Abdominal injection of bupivacaine into fascial layer. | 39 |
| Bupivacaine Liposome Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.
Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer. | 24 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-Up (30 Days After Discharge) | Study terminated prematurely | 39 | 22 |
| Initial Hospitalization | Study terminated prematurely | 0 | 1 |
| Initial Hospitalization | Withdrawal by study personnel | 0 | 1 |
Baseline characteristics
| Characteristic | Standard Bupivacaine | Total | Bupivacaine Liposome |
|---|---|---|---|
| Age, Continuous | 60.97 years STANDARD_DEVIATION 16.25 | 60.63 years STANDARD_DEVIATION 16.54 | 60.04 years STANDARD_DEVIATION 17.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 50 Participants | 20 Participants |
| Region of Enrollment United States | 39 Participants | 63 Participants | 24 Participants |
| Sex: Female, Male Female | 22 Participants | 35 Participants | 13 Participants |
| Sex: Female, Male Male | 17 Participants | 28 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 24 |
| other Total, other adverse events | 0 / 39 | 0 / 24 |
| serious Total, serious adverse events | 0 / 39 | 1 / 24 |
Outcome results
Primary
In-hospital Postoperative Opioid Consumption
Daily overall opioid use recorded as morphine equivalents
Time frame: up to postoperative day 3 at 1 pm
Population: The amount of in-hospital postoperative opioid consumption was going to be obtained from the charts, where it is recorded as standard of care. However, this study was terminated prematurely before data could be collected from the charts; therefore no data are available for this outcome measure.
Secondary
Complications
Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery
Time frame: Within 30 days of surgery
Population: Complications data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.
Secondary
Hospitalization Costs
Total hospitalization costs per patient per this surgical encounter
Time frame: From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).
Population: Cost data was intended to be collected through the finance department at the end of the study. However, the study was terminated prematurely, so cost data is not able to be obtained.
Secondary
In-hospital Antiemetic Use
Amount of ondansetron patient required postoperatively during hospital stay, in milligrams
Time frame: Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).
Population: Outcome data reported for subjects with non-missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Bupivacaine | In-hospital Antiemetic Use | 2.9 mg | Standard Deviation 3.6 |
| Bupivacaine Liposome | In-hospital Antiemetic Use | 5.6 mg | Standard Deviation 12.5 |
Secondary
Length of Stay
Total postoperative hospital stay in days
Time frame: Date of surgery to date of discharge (usually up to 4 days after surgery).
Population: Outcome data reported for subjects with non-missing data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Bupivacaine | Length of Stay | 3 days |
| Bupivacaine Liposome | Length of Stay | 3.5 days |
Secondary
Mortality
Patient death after surgery
Time frame: Within 30 days of surgery
Population: Mortality data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.
Secondary
Pain Score
Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)
Time frame: Approximately every 6 hours through postoperative day 3 by 1 pm
Population: Outcome data reported for patients with non-missing data. Pain scores presented are the first postoperative pain score per subject only due to missing data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Bupivacaine | Pain Score | 3 units on a scale |
| Bupivacaine Liposome | Pain Score | 3 units on a scale |
Secondary
Readmissions
Patient readmitted to hospital after discharge
Time frame: Within 30 days of hospital discharge
Population: Readmissions data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.
Secondary
Time to Clear Liquid Diet
Number of days from time of surgery until patient tolerates clear liquid diet
Time frame: From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).
Population: Outcome data reported for subjects with non-missing data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Bupivacaine | Time to Clear Liquid Diet | 0 days |
| Bupivacaine Liposome | Time to Clear Liquid Diet | 0 days |
Secondary
Time to Low Fiber Diet
Number of days from day of surgery until patient tolerates low fiber diet
Time frame: From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).
Population: Outcome data reported for subjects with non-missing data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Bupivacaine | Time to Low Fiber Diet | 1.5 days |
| Bupivacaine Liposome | Time to Low Fiber Diet | 1 days |
Secondary
Time to Patient Mobilization
Number of days from day of surgery until patient mobilization
Time frame: From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).
Population: Outcome data reported for subjects with non-missing data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Bupivacaine | Time to Patient Mobilization | 1 days |
| Bupivacaine Liposome | Time to Patient Mobilization | 0.5 days |
Secondary
Time to Return of Bowel Function
Number of days from time of surgery until return of bowel function
Time frame: From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).
Population: Outcome data reported for subjects with non-missing data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Bupivacaine | Time to Return of Bowel Function | 2 days |
| Bupivacaine Liposome | Time to Return of Bowel Function | 2 days |