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Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

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ClinicalTrials.gov Identifier: NCT03638635
Recruitment Status : Terminated (Lack of personnel available to complete study.)
First Posted : August 20, 2018
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Opioid Use
Pain, Postoperative
Colectomy
Colorectal Surgery
Interventions Drug: Bupivacaine
Drug: Bupivacaine liposome
Enrollment 63
Recruitment Details Patients were approached for consent in the hospital postoperatively to request the use of their data for research purposes.
Pre-assignment Details  
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description

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.

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.

Period Title: Initial Hospitalization
Started 39 24
Completed 39 22
Not Completed 0 2
Reason Not Completed
Study terminated prematurely             0             1
Withdrawal by study personnel             0             1
Period Title: Follow-Up (30 Days After Discharge)
Started 39 22
Completed 0 0
Not Completed 39 22
Reason Not Completed
Study terminated prematurely             39             22
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 39 24 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 24 participants 63 participants
60.97  (16.25) 60.04  (17.36) 60.63  (16.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 24 participants 63 participants
Female
22
  56.4%
13
  54.2%
35
  55.6%
Male
17
  43.6%
11
  45.8%
28
  44.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 24 participants 63 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   7.7%
2
   8.3%
5
   7.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   7.7%
2
   8.3%
5
   7.9%
White
30
  76.9%
20
  83.3%
50
  79.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   7.7%
0
   0.0%
3
   4.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 39 participants 24 participants 63 participants
39
 100.0%
24
 100.0%
63
 100.0%
1.Primary Outcome
Title In-hospital Postoperative Opioid Consumption
Hide Description Daily overall opioid use recorded as morphine equivalents
Time Frame up to postoperative day 3 at 1 pm
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Pain Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 37 21
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
3
(0 to 5)
3
(0 to 6)
3.Secondary Outcome
Title Time to Patient Mobilization
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data reported for subjects with non-missing data.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 29 18
Median (Inter-Quartile Range)
Unit of Measure: days
1
(0 to 1)
0.5
(0 to 1)
4.Secondary Outcome
Title Time to Return of Bowel Function
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data reported for subjects with non-missing data.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 28 18
Median (Inter-Quartile Range)
Unit of Measure: days
2
(1 to 2)
2
(1 to 2)
5.Secondary Outcome
Title Time to Clear Liquid Diet
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data reported for subjects with non-missing data.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 29 18
Median (Inter-Quartile Range)
Unit of Measure: days
0
(0 to 0)
0
(0 to 1)
6.Secondary Outcome
Title Time to Low Fiber Diet
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data reported for subjects with non-missing data.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 28 17
Median (Inter-Quartile Range)
Unit of Measure: days
1.5
(1 to 2.25)
1
(1 to 3)
7.Secondary Outcome
Title Length of Stay
Hide Description Total postoperative hospital stay in days
Time Frame Date of surgery to date of discharge (usually up to 4 days after surgery).
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data reported for subjects with non-missing data.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 31 18
Median (Inter-Quartile Range)
Unit of Measure: days
3
(3 to 5)
3.5
(3 to 5.75)
8.Secondary Outcome
Title In-hospital Antiemetic Use
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data reported for subjects with non-missing data.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 31 17
Mean (Standard Deviation)
Unit of Measure: mg
2.9  (3.6) 5.6  (12.5)
9.Secondary Outcome
Title Complications
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Complications data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Readmissions
Hide Description Patient readmitted to hospital after discharge
Time Frame Within 30 days of hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Readmissions data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Mortality
Hide Description Patient death after surgery
Time Frame Within 30 days of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Mortality data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Hospitalization Costs
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 30 days post-enrollment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Standard Bupivacaine Bupivacaine Liposome
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Bupivacaine Bupivacaine Liposome
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      1/24 (4.17%)    
Surgical and medical procedures     
Hospitalization * [1]  0/39 (0.00%)  0 1/24 (4.17%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Return to the operating room
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Bupivacaine Bupivacaine Liposome
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/24 (0.00%)    
Early termination due to lack of resources leading to incomplete data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Erica Emery
Organization: Inova Health System
Phone: 703-776-7615
EMail: erica.emery@inova.org
Publications:
Layout table for additonal information
Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT03638635     History of Changes
Other Study ID Numbers: 17-2725
First Submitted: August 21, 2017
First Posted: August 20, 2018
Results First Submitted: April 22, 2019
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019