Post-operative PainPhase 4NCT02052557
The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery
A Phase 4 study testing Bupivacaine and Bupivacaine liposome suspension in people with Post-operative Pain and Colon Cancer, run by Des Moines University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Colon Cancer, Diverticulitis
- What is being tested?
- Bupivacaine and Bupivacaine liposome suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective colon resection for both benign and malignant disease
- Laparoscopic, robotic and open techniques
Who cannot join
- 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
Show all 10Show fewer
- bupivacaine use within 96 hours
- allergy to amide anesthetics
- prisoners
- caution will be used in patients with renal or hepatic failure.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Post-operative Pain, Colon Cancer, Diverticulitis
- Being tested
- Bupivacaine, Bupivacaine liposome suspension
- Keywords
- Exparel, liposomal bupivicaine, post operative pain control, local anesthetic after surgery, colorectal surgery, marcaine, long acting local anesthetic, pain medication use after surgery
- Medical subject headings
- Pain, Postoperative, Colonic Neoplasms, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Bupivacaine liposome suspensionDrug
Also called Exparel, 72 hour Bupivacaine, Long acting Bupivacaine
30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | 30 milliliters (ml) of 0.5% marcaine with epinephrine Receives: Drug: Bupivacaine |
| Bupivacaine liposome suspension | Active comparator | exparel 20ml, diluted with 10ml sterile saline for total of 30ml Receives: Drug: Bupivacaine liposome suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCA (Patient Controlled Analgesia) Usage
Will measure the amount of PCA use for the first 48 hours after surgery.
Measured: 48 hours post operatively
Secondary outcomes (13)
Oral Pain Medications
the amount of post operative oral narcotic is measured post op
Measured: 48 hours postoperatively
Total IV (Intravenous) Narcotic Used
the total amount of IV narcotic is measured that is given during post op period prior to discharge
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Total Oral Narcotic Used
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Length of Stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Return of Bowel Function
Measured: 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
Measured: 30 days post operative readmission
Toradol Use
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Ofirmev
Measured: 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
Measured: The amount of nausea medicine used 48 hours post op was recorded
Foley Catheter Removal
Measured: 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
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.
Measured: POD #3-5 and POD #13-15
Post Operative Satisfaction
The investigators will ask the patient to rate their satisfaction with pain control.
Measured: POD #3-5 and POD #13-15
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
Measured: POD #13-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Des Moines University
- Sponsor type
- University, hospital or other
- Collaborators
- Mercy Medical Center
- Responsible party
- Sponsor
- Investigators
- Rachel Knudson, DO, Principal investigator, Mercy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052557
- Sponsor's protocol ID
- MMC2013-09
- Status last verified
- Dec 2020
- First submitted
- 24 Jan 2014
- Last updated
- 8 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.
PubMed 27505115
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery
- ClinicalTrials.gov ID
- NCT02052557
- Acronym / sponsor ID
- MMC2013-09
- Conditions
- Post-operative Pain, Colon Cancer, Diverticulitis
- Keywords
- Exparel, liposomal bupivicaine, post operative pain control, local anesthetic after surgery, colorectal surgery, marcaine, long acting local anesthetic, pain medication use after surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Des Moines UniversityUniversity, hospital or other
- Collaborators
- Mercy Medical Center
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: Bupivacaine30 milliliters (ml) of 0.5% marcaine with epinephrine |
| Bupivacaine liposome suspension | Active comparator | Drug: Bupivacaine liposome suspensionexparel 20ml, diluted with 10ml sterile saline for total of 30ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective colon resection for both benign and malignant disease
- Laparoscopic, robotic and open techniques
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: Marcaine30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR | Drug | Bupivacaine |
| Bupivacaine liposome suspensionAlso: Exparel, 72 hour Bupivacaine, Long acting Bupivacaine30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR | Drug | Bupivacaine liposome suspension |
Primary outcome
PCA (Patient Controlled Analgesia) Usage
Time frame: 48 hours post operatively
Will measure the amount of PCA use for the first 48 hours after surgery.
13 secondary outcomes
Oral Pain Medications
Time frame: 48 hours postoperatively
Total IV (Intravenous) Narcotic Used
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Total Oral Narcotic Used
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Length of Stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
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
Readmission
Time frame: 30 days post operative readmission
Toradol Use
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
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
Nausea Medication
Time frame: The amount of nausea medicine used 48 hours post op was recorded
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
Postoperative Pain
Time frame: POD #3-5 and POD #13-15
Post Operative Satisfaction
Time frame: POD #3-5 and POD #13-15
Home Oral Narcotic Use
Time frame: POD #13-15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27505115Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Knudson, DO principal investigator
Mercy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Bupivacaine liposome suspension in people with Post-operative Pain and Colon Cancer, run by Des Moines University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCA (Patient Controlled Analgesia) Usage (time frame: 48 hours post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02052557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.