Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery

Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery: A Prospective Randomized Trial

This study is prospective, randomized trial in which EXPAREL TAP block is compared to standard IT opioid administration, in relieving postoperative pain, decreasing length of stay, and use of narcotic medication.

Study Overview

• Status: Completed
• Conditions: Conditions Requiring Colorectal Surgery
• Intervention / Treatment: Drug: EXPAREL; Drug: Intrathecal hydromorphone

Detailed Description

Primary Objective To assess efficacy of EXPAREL TAP blocks in improving pain scores for 48 hours postoperatively, and in reducing total oral morphine equivalents (OME) use, compared to standard Intrathecal opioid administration (IT).

Secondary Objective Assess the length of stay (LOS), postoperative ileus (POI) incidence, and the use of intravenous patient controlled analgesia (PCA) in patients that had EXPAREL TAP blocs compared to IT.

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • All patients undergoing elective laparoscopic or open colorectal resections who are eligible for IT

  • Age >18 years
  • BMI <40
  • Ability to understand and read English

Exclusion Criteria:

• • Not able or unwilling to sign consent.

  • Currently pregnant or lactating.
  • Patients with chronic pain, requiring daily opiate use at time of surgery.
  • Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
  • Patients requiring emergent surgery.
  • Abdominoperineal resections
  • Any contraindications to neuraxial analgesia (coagulopathy, localized infection at the potential site of injection, pre-existing spinal canal pathology)
  • Patients with a diagnosis of inflammatory bowel disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAP block (EXPAREL); After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.	Drug: EXPAREL; transversus abdominis plane injection; Other Names: liposomal bupivacaine
Active Comparator: Intrathecal opioid (IT); single injection intrathecal hydromorphone analgesia given preoperatively	Drug: Intrathecal hydromorphone; Intrathecal opioid administration; Other Names: dilaudid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Pain Score	Postoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation.	First 48 hours post operative
Total Morphine Milligram Equivalents Use (MME)	The total cumulative use of opioids administered within 48 hours after surgery. MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies.	First 48 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Length of Hospital Stay	Length of stay was defined as the total number of nights spent in the hospital after surgery.	post-operative to discharge
Number of Participants With Post-operative Ileus	Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery.	24 hours post-operatively
Use of Intravenous Patient-controlled Analgesia	The total number of patients that used patient-controlled analgesia within 48 hours after surgery.	First 48 hours post-operative

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Dorin Colibaseanu, MD, Mayo Clinic

Publications and helpful links

General Publications

• Colibaseanu DT, Osagiede O, Merchea A, Ball CT, Bojaxhi E, Panchamia JK, Jacob AK, Kelley SR, Naessens JM, Larson DW. Randomized clinical trial of liposomal bupivacaine transverse abdominis plane block versus intrathecal analgesia in colorectal surgery. Br J Surg. 2019 May;106(6):692-699. doi: 10.1002/bjs.11141. Epub 2019 Mar 28.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: January 31, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 5, 2015

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Hydromorphone
• Other Study ID Numbers: 14-003143