Trial Outcomes & Findings for Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients (NCT NCT03638635)

NCT ID: NCT03638635

Last Updated: 2019-09-09

Results Overview

Daily overall opioid use recorded as morphine equivalents

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 63 participants
• Primary outcome timeframe: up to postoperative day 3 at 1 pm
• Results posted on: 2019-09-09

Participant Flow

Patients were approached for consent in the hospital postoperatively to request the use of their data for research purposes.

Participant milestones

Measure	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.	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.
Initial Hospitalization STARTED	39	24
Initial Hospitalization COMPLETED	39	22
Initial Hospitalization NOT COMPLETED	0	2
Follow-Up (30 Days After Discharge) STARTED	39	22
Follow-Up (30 Days After Discharge) COMPLETED	0	0
Follow-Up (30 Days After Discharge) NOT COMPLETED	39	22

Reasons for withdrawal

Measure	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.	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.
Initial Hospitalization Study terminated prematurely	0	1
Initial Hospitalization Withdrawal by study personnel	0	1
Follow-Up (30 Days After Discharge) Study terminated prematurely	39	22

Baseline Characteristics

Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

Baseline characteristics by cohort

Measure	Standard Bupivacaine n=39 Participants 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.	Bupivacaine Liposome n=24 Participants 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.	Total n=63 Participants Total of all reporting groups
Age, Continuous	60.97 years STANDARD_DEVIATION 16.25 • n=5 Participants	60.04 years STANDARD_DEVIATION 17.36 • n=7 Participants	60.63 years STANDARD_DEVIATION 16.54 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	20 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants	24 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Daily overall opioid use recorded as morphine equivalents

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)

Outcome measures

Measure	Standard Bupivacaine n=37 Participants 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.	Bupivacaine Liposome n=21 Participants 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.
Pain Score	3 units on a scale Interval 0.0 to 5.0	3 units on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 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.

Number of days from day of surgery until patient mobilization

Outcome measures

Measure	Standard Bupivacaine n=29 Participants 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.	Bupivacaine Liposome n=18 Participants 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.
Time to Patient Mobilization	1 days Interval 0.0 to 1.0	0.5 days Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 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.

Number of days from time of surgery until return of bowel function

Outcome measures

Measure	Standard Bupivacaine n=28 Participants 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.	Bupivacaine Liposome n=18 Participants 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.
Time to Return of Bowel Function	2 days Interval 1.0 to 2.0	2 days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: 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.

Number of days from time of surgery until patient tolerates clear liquid diet

Outcome measures

Measure	Standard Bupivacaine n=29 Participants 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.	Bupivacaine Liposome n=18 Participants 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.
Time to Clear Liquid Diet	0 days Interval 0.0 to 0.0	0 days Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 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.

Number of days from day of surgery until patient tolerates low fiber diet

Outcome measures

Measure	Standard Bupivacaine n=28 Participants 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.	Bupivacaine Liposome n=17 Participants 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.
Time to Low Fiber Diet	1.5 days Interval 1.0 to 2.25	1 days Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Date of surgery to date of discharge (usually up to 4 days after surgery).

Population: Outcome data reported for subjects with non-missing data.

Total postoperative hospital stay in days

Outcome measures

Measure	Standard Bupivacaine n=31 Participants 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.	Bupivacaine Liposome n=18 Participants 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.
Length of Stay	3 days Interval 3.0 to 5.0	3.5 days Interval 3.0 to 5.75

SECONDARY outcome

Timeframe: 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.

Amount of ondansetron patient required postoperatively during hospital stay, in milligrams

Outcome measures

Measure	Standard Bupivacaine n=31 Participants 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.	Bupivacaine Liposome n=17 Participants 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.
In-hospital Antiemetic Use	2.9 mg Standard Deviation 3.6	5.6 mg Standard Deviation 12.5

SECONDARY outcome

Timeframe: 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.

Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Patient readmitted to hospital after discharge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Patient death after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Total hospitalization costs per patient per this surgical encounter

Outcome measures

Outcome data not reported

Adverse Events

Standard Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine Liposome

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Bupivacaine n=39 participants at risk 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.	Bupivacaine Liposome n=24 participants at risk 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.
Surgical and medical procedures Hospitalization	0.00% 0/39 • 30 days post-enrollment	4.2% 1/24 • Number of events 1 • 30 days post-enrollment

Other adverse events

Adverse event data not reported

Additional Information

Erica Emery

Inova Health System

Phone: 703-776-7615

Email: erica.emery@inova.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place