The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery

Phase 4

Completed

Conditions: Post-operative Pain
Diverticulitis
Colon Cancer

Interventions: Drug: Bupivacaine liposome suspension
Drug: Bupivacaine

Registration Number: NCT02052557

Lead Sponsor: Des Moines University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine liposome suspension	Bupivacaine liposome suspension	exparel 20ml, diluted with 10ml sterile saline for total of 30ml
Bupivacaine	Bupivacaine	30 milliliters (ml) of 0.5% marcaine with epinephrine

Primary Outcome Measures

Name	Time	Method
PCA (Patient Controlled Analgesia) Usage	48 hours post operatively	Will measure the amount of PCA use for the first 48 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
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
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
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
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.
Toradol Use	participants will be followed for the duration of hospital stay, an expected average of 3 days
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
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