Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery

Mayo Clinic

Status: Completed

Conditions: Conditions Requiring Colorectal Surgery

Treatments: Drug: Intrathecal hydromorphone; Drug: EXPAREL

Study type: Interventional

Funder types: Other

Identifiers

NCT02356198

14-003143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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209 participants in 2 patient groups

TAP block (EXPAREL)

Active Comparator group

Description:

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.

Treatment:

Drug: EXPAREL

Intrathecal opioid (IT)

Active Comparator group

Description:

single injection intrathecal hydromorphone analgesia given preoperatively

Treatment:

Drug: Intrathecal hydromorphone