NCT02356198

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 5, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

2.6 years

First QC Date

January 31, 2015

Results QC Date

January 15, 2019

Last Update Submit

March 1, 2019

Conditions

Conditions Requiring Colorectal Surgery

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    First 48 hours post operative

Secondary Outcomes (3)

  • Total Length of Hospital Stay

    post-operative to discharge

  • Number of Participants With Post-operative Ileus

    24 hours post-operatively

  • Use of Intravenous Patient-controlled Analgesia

    First 48 hours post-operative

Study Arms (2)

TAP block (EXPAREL)

ACTIVE COMPARATOR

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.

Drug: EXPAREL

Intrathecal opioid (IT)

ACTIVE COMPARATOR

single injection intrathecal hydromorphone analgesia given preoperatively

Drug: Intrathecal hydromorphone

Interventions

EXPARELDRUG

transversus abdominis plane injection

Also known as: liposomal bupivacaine
TAP block (EXPAREL)
Intrathecal hydromorphoneDRUG

Intrathecal opioid administration

Also known as: dilaudid
Intrathecal opioid (IT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

  • Colibaseanu DT, Osagiede O, Merchea A, Ball CT, Bojaxhi E, Panchamia JK, Jacob AK, Kelley SR, Naessens JM, Larson DW. Randomized clinical trial of liposomal bupivacaine transverse abdominis plane block versus intrathecal analgesia in colorectal surgery. Br J Surg. 2019 May;106(6):692-699. doi: 10.1002/bjs.11141. Epub 2019 Mar 28.

    PMID: 30919948DERIVED

Related Links

MeSH Terms

Interventions

Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Dr. Dorin T. Colibaseanu, MD
Organization
Mayo Clinic
colibaseanu.dorin@mayo.edu
904-953-2596

Study Officials

  • Dorin Colibaseanu, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 31, 2015

First Posted

February 5, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

March 7, 2019

Results First Posted

February 5, 2019

Record last verified: 2019-03

Locations

US(1)