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

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.

Study Overview

• Status: Completed
• Conditions: Diverticulitis; Colon Cancer; Post-operative Pain
• Intervention / Treatment: Drug: Bupivacaine; Drug: Bupivacaine liposome suspension

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine; 30 milliliters (ml) of 0.5% marcaine with epinephrine	Drug: Bupivacaine; 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR; Other Names: Marcaine
Active Comparator: Bupivacaine liposome suspension; exparel 20ml, diluted with 10ml sterile saline for total of 30ml	Drug: Bupivacaine liposome suspension; 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR; Other Names: Exparel; 72 hour Bupivacaine; Long acting Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCA (Patient Controlled Analgesia) Usage	Will measure the amount of PCA use for the first 48 hours after surgery.	48 hours post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Pain Medications	the amount of post operative oral narcotic is measured post op	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	participants will be followed for the duration of hospital stay, an expected average of 3 days
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
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
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	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.	POD #3-5 and POD #13-15
Post Operative Satisfaction	The investigators will ask the patient to rate their satisfaction with pain control.	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	POD #13-15

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NG (Nasogastric) Placement	We recorded if an NG was placed immediately post operatively	POD #0 if NG was placed

Collaborators and Investigators

• Sponsor: Des Moines University
• Collaborators: Mercy Medical Center
• Investigators: Principal Investigator: Rachel Knudson, DO, Mercy Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: colorectal surgery; Exparel; liposomal bupivicaine; post operative pain control; local anesthetic after surgery; marcaine; long acting local anesthetic; pain medication use after surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Pain, Postoperative; Diverticulitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MMC2013-09