Clinical trial NCT02052557: The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery
Official title: The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Des Moines University
Sponsor class: OTHER
Collaborators: name: Mercy Medical Center
First posted: 2014-02-03
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PCA (Patient Controlled Analgesia) Usage
timeFrame: 48 hours post operatively
Secondary outcomes:
measure: Oral Pain Medications
timeFrame: 48 hours postoperatively
measure: Total IV (Intravenous) Narcotic Used
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Total Oral Narcotic Used
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Length of Stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Return of Bowel Function
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
measure: Readmission
timeFrame: 30 days post operative readmission
measure: Toradol Use
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Ofirmev
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
measure: Nausea Medication
timeFrame: The amount of nausea medicine used 48 hours post op was recorded
measure: Foley Catheter Removal
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
measure: Postoperative Pain
timeFrame: POD #3-5 and POD #13-15
measure: Post Operative Satisfaction
timeFrame: POD #3-5 and POD #13-15
measure: Home Oral Narcotic Use
timeFrame: POD #13-15
Other outcomes:
measure: NG (Nasogastric) Placement
timeFrame: POD #0 if NG was placed
Locations:
city: Des Moines
country: United States
facility: Mercy Medical Center
state: Iowa
Study officials:
affiliation: Mercy Medical Center
name: Rachel Knudson, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.