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
|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 :||209 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 20 milliliters (mL) of injectable saline.
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
- 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.
- 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.
- 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.
- 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.
- 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.
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|
|Principal Investigator:||Dorin Colibaseanu, MD||Mayo Clinic|