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

NCT03723447 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00053363
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Crohn Disease; Inflammatory Bowel Diseases; Colorectal Cancer; Gastrointestinal Cancer; Gastrointestinal Disease; Digestive System Disease; Pain; Pain, Neuropathic; Intestinal Disease

Keywords

transversus abdominis plane block; tap block; liposomal bupivacaine; exparel; dexamethasone; colorectal surgery; regional anesthesia; bupivacaine; surgery; postoperative pain; pain

Outcome Measures

Primary Outcomes (1)

• Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)

  48-hours

Secondary Outcomes (4)

• Post-op Pain Score (Visual Analog Scale)

  72-hours post-surgery

• Bowel Motility

  72 hours post-surgery

• Postoperative Length of Stay

  30 days post-surgery

• Postoperative Complications

  30 days post-surgery

Study Arms (2)

Bupivacaine/epinephrine/dexamethasone TAP block

ACTIVE COMPARATOR

For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.

Drug: Bupivacaine/epinephrine/dexamethasone

Liposomal bupivacaine TAP block

ACTIVE COMPARATOR

For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.

Also known as: Exparel

Liposomal bupivacaine TAP block

Bupivacaine/epinephrine/dexamethasone DRUG

Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.

Also known as: Decadron

Bupivacaine/epinephrine/dexamethasone TAP block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (4)

• Mujukian A, Truong A, Tran H, Shane R, Fleshner P, Zaghiyan K. A Standardized Multimodal Analgesia Protocol Reduces Perioperative Opioid Use in Minimally Invasive Colorectal Surgery. J Gastrointest Surg. 2020 Oct;24(10):2286-2294. doi: 10.1007/s11605-019-04385-9. Epub 2019 Sep 12.

  PMID: 31515761 BACKGROUND

• Truong A, Mujukian A, Fleshner P, Zaghiyan K. No Pain, More Gain: Reduced Postoperative Opioid Consumption with a Standardized Opioid-Sparing Multimodal Analgesia Protocol in Opioid-Tolerant Patients Undergoing Colorectal Surgery. Am Surg. 2019 Oct 1;85(10):1155-1158.

  PMID: 31657314 BACKGROUND

• 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 BACKGROUND

• Truong A, Fleshner PR, Mirocha JM, Tran HP, Shane R, Zaghiyan KN. A Prospective Randomized Trial of Surgeon-Administered Intraoperative Transversus Abdominis Plane Block With Bupivacaine Against Liposomal Bupivacaine: The TINGLE Trial. Dis Colon Rectum. 2021 Jul 1;64(7):888-898. doi: 10.1097/DCR.0000000000002008.

  PMID: 34086002 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Crohn Disease; Inflammatory Bowel Diseases; Colorectal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neuralgia; Intestinal Diseases

Interventions

Bupivacaine; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Gastroenteritis; Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Rectal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr Karen Zaghiyan
• Organization: Cedars-Sinai

kzaghiyan@yahoo.com

(310) 289-9224

Study Officials

• Karen Zaghiyan, MD

  Cedars Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon Investigator

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 29, 2018
• Study Start: October 23, 2018
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)