Completed

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

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What is being tested

Bupivacaine

+ Bupivacaine liposome suspension

Drug
Who is being recruted

Diverticular Diseases+18

+ Colonic Diseases

+ Colonic Neoplasms

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 4
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorDes Moines University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleThe Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery
NCT02052557
Principal SponsorDes Moines University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

51 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diverticular DiseasesColonic DiseasesColonic NeoplasmsDigestive System DiseasesDigestive System NeoplasmsDiverticulitisGastroenteritisGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteNeurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsColorectal Neoplasms

Criteria

2 inclusion criteria required to participate
Elective colon resection for both benign and malignant disease

Laparoscopic, robotic and open techniques

10 exclusion criteria prevent from participating
emergent colon cases

cases preformed by surgeons other than Dr. Raman or Dr. Kraemer

pregnant patients

patients currently breast feeding

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
30 milliliters (ml) of 0.5% marcaine with epinephrine

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Mercy Medical Center

Des Moines, United StatesOpen Mercy Medical Center in Google Maps
CompletedOne Study Center