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

NCT02052557 | Completed Phase 4 Results

• 1 other identifier: MMC2013-09
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• PCA (Patient Controlled Analgesia) Usage

  Will measure the amount of PCA use for the first 48 hours after surgery.

  48 hours post operatively

Secondary Outcomes (13)

• Oral Pain Medications

  48 hours postoperatively

• Total IV (Intravenous) Narcotic Used

  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

Other Outcomes (1)

• NG (Nasogastric) Placement

  POD #0 if NG was placed

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

30 milliliters (ml) of 0.5% marcaine with epinephrine

Drug: Bupivacaine

Bupivacaine liposome suspension

ACTIVE COMPARATOR

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

Drug: Bupivacaine liposome suspension

Interventions

Bupivacaine DRUG

30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR

Also known as: Marcaine

Bupivacaine

Bupivacaine liposome suspension DRUG

30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR

Also known as: Exparel, 72 hour Bupivacaine, Long acting Bupivacaine

Bupivacaine liposome suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective colon resection for both benign and malignant disease
• Laparoscopic, robotic and open techniques

You may not qualify if:

• 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.

Sponsors & Collaborators

• Des Moines University: lead
• Mercy Medical Center: collaborator

Study Sites (1)

Mercy Medical Center

Des Moines, Iowa, 50314, United States

Location

Related Publications (1)

• 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.

  PMID: 27505115 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Colonic Neoplasms; Diverticulitis

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Diverticular Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Grants and Contracts Manager
• Organization: Des Moines University

mlyon@dmu.edu

5152711657

Study Officials

• Rachel Knudson, DO

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: February 3, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 8, 2021
• Results First Posted: January 8, 2021

Record last verified: 2020-12

Locations

US (1)