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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

Page last updated: August 23, 2015

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