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

NCT ID: NCT02052557

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-12-31

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.

Conditions

Post-operative Pain; Colon Cancer; Diverticulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Bupivacaine

30 milliliters (ml) of 0.5% marcaine with epinephrine

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Bupivacaine liposome suspension

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine liposome suspension

Intervention Type: DRUG

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

Interventions

Bupivacaine

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Marcaine; Exparel; 72 hour Bupivacaine; Long acting Bupivacaine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mercy Medical Center

OTHER

Sponsor Role: collaborator

Des Moines University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Knudson, DO

Role: PRINCIPAL_INVESTIGATOR

Mercy Medical Center

Locations

Mercy Medical Center

Des Moines, Iowa, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27505115 (View on PubMed)

Other Identifiers

MMC2013-09

Identifier Type: -

Identifier Source: org_study_id