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

Primary Purpose

Post-operative Pain, Colon Cancer, Diverticulitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Bupivacaine liposome suspension
Sponsored by
Des Moines University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-operative Pain focused on measuring Exparel, liposomal bupivicaine, post operative pain control, local anesthetic after surgery, colorectal surgery, marcaine, long acting local anesthetic, pain medication use after surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mercy Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bupivacaine

Bupivacaine liposome suspension

Arm Description

30 milliliters (ml) of 0.5% marcaine with epinephrine

exparel 20ml, diluted with 10ml sterile saline for total of 30ml

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oral Pain Medications
the amount of post operative oral narcotic is measured post op
Total IV (Intravenous) Narcotic Used
the total amount of IV narcotic is measured that is given during post op period prior to discharge
Total Oral Narcotic Used
Length of Stay
Return of Bowel Function
Readmission
Toradol Use
Ofirmev
Nausea Medication
Foley Catheter Removal
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.
Post Operative Satisfaction
The investigators will ask the patient to rate their satisfaction with pain control.
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

Full Information

First Posted
January 24, 2014
Last Updated
December 14, 2020
Sponsor
Des Moines University
Collaborators
Mercy Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02052557
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Des Moines University
Collaborators
Mercy Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
30 milliliters (ml) of 0.5% marcaine with epinephrine
Arm Title
Bupivacaine liposome suspension
Arm Type
Active Comparator
Arm Description
exparel 20ml, diluted with 10ml sterile saline for total of 30ml
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Intervention Type
Drug
Intervention Name(s)
Bupivacaine liposome suspension
Other Intervention Name(s)
Exparel, 72 hour Bupivacaine, Long acting Bupivacaine
Intervention Description
30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
Primary Outcome Measure Information:
Title
PCA (Patient Controlled Analgesia) Usage
Description
Will measure the amount of PCA use for the first 48 hours after surgery.
Time Frame
48 hours post operatively
Secondary Outcome Measure Information:
Title
Oral Pain Medications
Description
the amount of post operative oral narcotic is measured post op
Time Frame
48 hours postoperatively
Title
Total IV (Intravenous) Narcotic Used
Description
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
Title
Total Oral Narcotic Used
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 days
Title
Length of Stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 days
Title
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
Title
Readmission
Time Frame
30 days post operative readmission
Title
Toradol Use
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 days
Title
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
Title
Nausea Medication
Time Frame
The amount of nausea medicine used 48 hours post op was recorded
Title
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
Title
Postoperative Pain
Description
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
Title
Post Operative Satisfaction
Description
The investigators will ask the patient to rate their satisfaction with pain control.
Time Frame
POD #3-5 and POD #13-15
Title
Home Oral Narcotic Use
Description
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
Other Pre-specified Outcome Measures:
Title
NG (Nasogastric) Placement
Description
We recorded if an NG was placed immediately post operatively
Time Frame
POD #0 if NG was placed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Knudson, DO
Organizational Affiliation
Mercy Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27505115
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.
Results Reference
derived

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

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