Completed

NCT Number: NCT02356198

Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery

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.

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Key information

Conditions

Conditions Requiring Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exparel

Drug

transversus abdominis plane injection

Other names: liposomal bupivacaine

Intrathecal hydromorphone

Drug

Intrathecal opioid administration

Other names: dilaudid

Primary outcomes

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.

Secondary outcomes

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.
Number of Participants With 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery: A Prospective Randomized Trial

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Feb 5, 2015
Registry last updated: Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.