Trial Outcomes & Findings for The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery (NCT NCT02052557)

Results Overview

Will measure the amount of PCA use for the first 48 hours after surgery.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

48 hours post operatively

Results posted on

2021-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Bupivacaine 30 milliliters (ml) of 0.5% marcaine with epinephrine Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR	Bupivacaine Liposome Suspension exparel 20ml, diluted with 10ml sterile saline for total of 30ml Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Overall Study STARTED	26	25
Overall Study COMPLETED	26	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupivacaine n=26 Participants 30 milliliters (ml) of 0.5% marcaine with epinephrine Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR	Bupivacaine Liposome Suspension n=25 Participants exparel 20ml, diluted with 10ml sterile saline for total of 30ml Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.	0 Participants The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.	0 Participants The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.
Age, Categorical Between 18 and 65 years	0 Participants The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.	0 Participants The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.	0 Participants The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.
Age, Categorical >=65 years	0 Participants The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.	0 Participants The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.	0 Participants The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.
Age, Continuous	67 years STANDARD_DEVIATION 2 • n=26 Participants	67 years STANDARD_DEVIATION 2 • n=25 Participants	67 years STANDARD_DEVIATION 2 • n=51 Participants
Sex: Female, Male Female	11 Participants n=26 Participants	11 Participants n=25 Participants	22 Participants n=51 Participants
Sex: Female, Male Male	15 Participants n=26 Participants	14 Participants n=25 Participants	29 Participants n=51 Participants
Region of Enrollment United States	26 participants n=26 Participants	25 participants n=25 Participants	51 participants n=51 Participants

PRIMARY outcome

Timeframe: 48 hours post operatively

Population: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

Will measure the amount of PCA use for the first 48 hours after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours postoperatively

Population: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

the amount of post operative oral narcotic is measured post op

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days

Population: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

the total amount of IV narcotic is measured that is given during post op period prior to discharge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days

Population: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days

Outcome measures

Outcome measures
Measure	Bupivacaine n=26 Participants 30 milliliters (ml) of 0.5% marcaine with epinephrine Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR	Bupivacaine Liposome Suspension n=25 Participants exparel 20ml, diluted with 10ml sterile saline for total of 30ml Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Length of Stay	4 days	6 days

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days, and the timing of return of bowel function returning will be recorded

Population: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days post operative readmission

Population: No one readmitted.

Outcome measures

Outcome measures
Measure	Bupivacaine n=26 Participants 30 milliliters (ml) of 0.5% marcaine with epinephrine Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR	Bupivacaine Liposome Suspension n=25 Participants exparel 20ml, diluted with 10ml sterile saline for total of 30ml Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Readmission	0 Participants	0 Participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days

Outcome measures

Outcome measures
Measure	Bupivacaine n=26 Participants 30 milliliters (ml) of 0.5% marcaine with epinephrine Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR	Bupivacaine Liposome Suspension n=25 Participants exparel 20ml, diluted with 10ml sterile saline for total of 30ml Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Toradol Use	1 Participants	0 Participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days, and the amount of ofirmev used during admission will be recorded

Population: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The amount of nausea medicine used 48 hours post op was recorded

Population: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days, the timing of foley catheter removal will be recorded

Population: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: POD #3-5 and POD #13-15

Population: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

The investigators will talk to the patient after surgery immediately post operatively Post Operative Day (POD) #3-5 and POD #13-15 and ask the patients to rate their pain on a scale of 1-10.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: POD #3-5 and POD #13-15

Population: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.

The investigators will ask the patient to rate their satisfaction with pain control.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: POD #13-15

The investigators will ask the patients how many of their narcotic pain pills they used after surgery up to the POD #13-15

Outcome measures

Outcome measures
Measure	Bupivacaine n=25 Participants 30 milliliters (ml) of 0.5% marcaine with epinephrine Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR	Bupivacaine Liposome Suspension n=26 Participants exparel 20ml, diluted with 10ml sterile saline for total of 30ml Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Home Oral Narcotic Use	2 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: POD #0 if NG was placed

We recorded if an NG was placed immediately post operatively

Outcome measures

Outcome data not reported

Adverse Events

Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine Liposome Suspension

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Grants and Contracts Manager

Des Moines University

Phone: 5152711657

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place