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
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Conditions Requiring Colorectal Surgery||Drug: EXPAREL Drug: Intrathecal hydromorphone||Not Applicable|
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 :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 20mL of injectable saline.
transversus abdominis plane injection
Other Name: liposomal bupivacaine
Active Comparator: IT
single injection intrathecal hydromorphone analgesia given preoperatively
Drug: Intrathecal hydromorphone
Intrathecal opioid administration
Other Name: dilaudid
- Pain scores [ Time Frame: First 48 hours post op. ]mean pain scores for 48 hours after surgery.
- Length of stay [ Time Frame: Post operative ]Length of stay days post operative.
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
|United States, Florida|
|Mayo Clinic Florida|
|Jacksonville, Florida, United States, 32224|