Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Conditions Requiring Colorectal Surgery
Intervention: EXPAREL (Drug); Intrathecal hydromorphone (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Mayo Clinic Overall contact: Mauricia A Buchanan, RN, Phone: 904-953-2596, Email: buchanan.mauricia@mayo.edu
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.
Clinical Details
Official title: Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery: A Prospective Randomized Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pain scores
Secondary outcome: Length of stay
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- • All patients undergoing elective laparoscopic or open colorectal resections who are
eligible for IT, and able to be enrolled in ERP.
- 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
Locations and Contacts
Mauricia A Buchanan, RN, Phone: 904-953-2596, Email: buchanan.mauricia@mayo.edu Additional Information
Starting date: March 2015
Last updated: March 9, 2015
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