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Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT02356198
Recruitment Status : Completed
First Posted : February 5, 2015
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dorin T. Colibaseanu, M.D., Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Conditions Requiring Colorectal Surgery Drug: EXPAREL Drug: Intrathecal hydromorphone Not Applicable

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  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery: A Prospective Randomized Trial
Study Start Date : March 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: liposomal bupivacaine

Active Comparator: Intrathecal opioid (IT)
single injection intrathecal hydromorphone analgesia given preoperatively
Drug: Intrathecal hydromorphone
Intrathecal opioid administration
Other Name: dilaudid




Primary Outcome Measures :
  1. Mean Pain Score [ Time Frame: First 48 hours post operative ]
    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.

  2. Total Morphine Milligram Equivalents Use (MME) [ Time Frame: First 48 hours post operative ]
    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.


Secondary Outcome Measures :
  1. Total Length of Hospital Stay [ Time Frame: post-operative to discharge ]
    Length of stay was defined as the total number of nights spent in the hospital after surgery.

  2. Incidence of Post-operative Ileus [ Time Frame: 24 hours post-operatively ]
    Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery.

  3. Use of Intravenous Patient-controlled Analgesia [ Time Frame: First 48 hours post-operative ]
    The total number of patients that used patient-controlled analgesia within 48 hours after surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356198


Locations
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Dorin Colibaseanu, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Dorin T. Colibaseanu, M.D., Mayo Clinic:

Responsible Party: Dorin T. Colibaseanu, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02356198     History of Changes
Other Study ID Numbers: 14-003143
First Posted: February 5, 2015    Key Record Dates
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents