Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)

Completed · Phase 4

Conditions studied: Pain, Postoperative, Crohn Disease, Inflammatory Bowel Diseases, Colorectal Cancer, Gastrointestinal Cancer, Gastrointestinal Disease, Digestive System Disease, Pain, Pain, Neuropathic, Intestinal Disease

In brief

Traditionally, opioids are heavily utilized in treating postoperative pain but they are associated with numerous side effects. The use of the transversus abdominis plane (TAP) blocks have become standard practice to extend the post-operative analgesic window and limit opioid use. A new liposomal-depo formulation of bupivacaine (Exparel) has gained popularity as a long-lasting TAP block medication, but has not been studied in a well-powered clinical trial specifically in colorectal patients nor compared to a bupivacaine/steroid mixture which may offer similar effects. We conduct a prospective randomized prospective randomized study of patients undergoing major laparoscopic colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus liposomal bupivacaine.

Key facts

Study ID

NCT03723447

Run by

Cedars-Sinai Medical Center

People needed

102

Starts

2018-10-23

Expected to finish

2019-10-29

Last updated by the study team

2021-02-17

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female
• Undergoing major laparoscopic colorectal procedure
• Willingness and ability to sign an informed consent document
• No allergies to anesthetic or analgesic medications
• ASA physical status Class I - III
• Aged 18-90 years

You may not qualify if…

• Refusal to participate in the study
• Age <18 or > 90 years
• Pregnancy
• Contraindications to regional anesthetic including but not limited to:
• Patient refusal to regional field blockade
• Allergy
• Infection at the site of needle insertion
• Systemic infection
• Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory evaluation)
• Liver or renal disease (SCr > 1.5)
• Chronic opioid use

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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