Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery

Mayo Clinic209 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

209

Conditions

Conditions Requiring Colorectal Surgery

Interventions

EXPARELDRUG

transversus abdominis plane injection

Intrathecal hydromorphoneDRUG

Intrathecal opioid administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Mean Pain Score

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.

Time frame: First 48 hours post operative

Total Morphine Milligram Equivalents Use (MME)

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.

Time frame: First 48 hours post operative

Secondary Outcomes

Total Length of Hospital Stay

Length of stay was defined as the total number of nights spent in the hospital after surgery.

Time frame: post-operative to discharge

Number of Participants With Post-operative Ileus

Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery.

Time frame: 24 hours post-operatively

Use of Intravenous Patient-controlled Analgesia

The total number of patients that used patient-controlled analgesia within 48 hours after surgery.

Time frame: First 48 hours post-operative

Data from ClinicalTrials.gov

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