Colon Cancer, Diverticulitis, Post-operative Pain
Conditions
Keywords
Exparel, liposomal bupivicaine, post operative pain control, local anesthetic after surgery, colorectal surgery, marcaine, long acting local anesthetic, pain medication use after surgery
Brief summary
The purpose of the study is to evaluate the effect of Exparel on pain control and patient outcome after colon resection. The investigators will evaluate the clinical course of the patients who receive exparel as compared to the patients who do not receive exparel. Exparel is a 72 hour bupivacaine which is slowly released from lysosomes over the course of three days. A long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5 hour half-life.
Detailed description
Patients who are undergoing elective colon resection with Dr. Kraemer and Dr. Raman will be offered participation in the study. This will include robotic, laparoscopic and open procedures. In the pre-operative area prior to surgery, the surgical resident will inform the patient of the opportunity to participate in the research study. The resident will consent the patient at that time, if the patient chooses to participate, they will be randomized to an exparel or non-exparel group. The randomization will be done by having the resident pick an envelope that will state whether or not the patient is randomized to the exparel or non-exparel group, this will randomize to 50% in each group. The patient will not be notified of the type of local anesthetic they receive. The attending surgeon will also be blind to the type of local the pt will receive; only the resident and Operating Room (OR) staff will know what type of local anesthetic was given. Unfortunately the opaque color of the exparel precludes the physician injecting the local anesthetic from being blinded to the type of anesthetic given. The patient will be taken to the operating room as usual, and the surgery will proceed as it normally would. At the end of the surgery the patient will receive either exparel or bupivacaine depending upon which the patient was randomized to. The attending surgeon will not be in the operating suite while the local anesthetic is being injected. 30 milliliters (mL) of either exparel or bupivacaine will be injected into the subcutaneous tissues at the end of surgery. The patient will be taken to the post operative care unit (PACU), the medications for post-operative pain will be standardized between the two groups, a standard starting dose on the patient controlled analgesia (PCA) will be used, and will be adjusted as needed. The postoperative care will attempt to be standardized in regard to diet, discharge (dc) of foley, not using nasogastric (NG) tubes, however this will be based on the individual patient was what is best for their care. This data will then be analyzed to determine if exparel has a beneficial effect on surgical care.
Interventions
DRUGBupivacaine
30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Sponsors
Mercy Medical Center
Des Moines University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Elective colon resection for both benign and malignant disease * Laparoscopic, robotic and open techniques
Exclusion criteria
* emergent colon cases * cases preformed by surgeons other than Dr. Raman or Dr. Kraemer * pregnant patients * patients currently breast feeding * patients under the age of 18 * other patients unable to give informed consent * bupivacaine use within 96 hours * allergy to amide anesthetics * prisoners * caution will be used in patients with renal or hepatic failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCA (Patient Controlled Analgesia) Usage | 48 hours post operatively | Will measure the amount of PCA use for the first 48 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Pain Medications | 48 hours postoperatively | the amount of post operative oral narcotic is measured post op |
| Total IV (Intravenous) Narcotic Used | participants will be followed for the duration of hospital stay, an expected average of 3 days | the total amount of IV narcotic is measured that is given during post op period prior to discharge |
| Total Oral Narcotic Used | participants will be followed for the duration of hospital stay, an expected average of 3 days | — |
| Length of Stay | participants will be followed for the duration of hospital stay, an expected average of 3 days | — |
| Return of Bowel Function | 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 | — |
| Readmission | 30 days post operative readmission | — |
| Ofirmev | 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 | — |
| Nausea Medication | The amount of nausea medicine used 48 hours post op was recorded | — |
| Foley Catheter Removal | 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 | — |
| Postoperative Pain | POD #3-5 and POD #13-15 | 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. |
| Post Operative Satisfaction | POD #3-5 and POD #13-15 | The investigators will ask the patient to rate their satisfaction with pain control. |
| Home Oral Narcotic Use | 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 |
| Toradol Use | participants will be followed for the duration of hospital stay, an expected average of 3 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| NG (Nasogastric) Placement | POD #0 if NG was placed | We recorded if an NG was placed immediately post operatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 25 |
| Total | 51 |
Baseline characteristics
| Characteristic | Bupivacaine Liposome Suspension | Bupivacaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 2 | 67 years STANDARD_DEVIATION 2 | 67 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 25 participants | 26 participants | 51 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
PCA (Patient Controlled Analgesia) Usage
Will measure the amount of PCA use for the first 48 hours after surgery.
Time frame: 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.
Secondary
Foley Catheter Removal
Time frame: 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.
Secondary
Home Oral Narcotic Use
The investigators will ask the patients how many of their narcotic pain pills they used after surgery up to the POD #13-15
Time frame: POD #13-15
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivacaine | Home Oral Narcotic Use | 2 Participants |
| Bupivacaine Liposome Suspension | Home Oral Narcotic Use | 5 Participants |
Secondary
Length of Stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupivacaine | Length of Stay | 4 days |
| Bupivacaine Liposome Suspension | Length of Stay | 6 days |
Secondary
Nausea Medication
Time frame: 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.
Secondary
Ofirmev
Time frame: 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.
Secondary
Oral Pain Medications
the amount of post operative oral narcotic is measured post op
Time frame: 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.
Secondary
Postoperative Pain
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.
Time frame: 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.
Secondary
Post Operative Satisfaction
The investigators will ask the patient to rate their satisfaction with pain control.
Time frame: 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.
Secondary
Readmission
Time frame: 30 days post operative readmission
Population: No one readmitted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivacaine | Readmission | 0 Participants |
| Bupivacaine Liposome Suspension | Readmission | 0 Participants |
Secondary
Return of Bowel Function
Time frame: 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.
Secondary
Toradol Use
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivacaine | Toradol Use | 1 Participants |
| Bupivacaine Liposome Suspension | Toradol Use | 0 Participants |
Secondary
Total IV (Intravenous) Narcotic Used
the total amount of IV narcotic is measured that is given during post op period prior to discharge
Time frame: 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.
Secondary
Total Oral Narcotic Used
Time frame: 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.
Other Pre-specified
NG (Nasogastric) Placement
We recorded if an NG was placed immediately post operatively
Time frame: POD #0 if NG was placed