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Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

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ClinicalTrials.gov Identifier: NCT03638635
Recruitment Status : Terminated (Lack of personnel available to complete study.)
First Posted : August 20, 2018
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

Brief Summary:
The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.

Condition or disease Intervention/treatment Phase
Opioid Use Pain, Postoperative Colectomy Colorectal Surgery Drug: Bupivacaine Drug: Bupivacaine liposome Phase 4

Detailed Description:

Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects.

Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively).

In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The participant and the floor nursing staff recording pain scores will be blinded to the assigned intervention.
Primary Purpose: Supportive Care
Official Title: TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial
Actual Study Start Date : May 14, 2018
Actual Primary Completion Date : January 16, 2019
Actual Study Completion Date : January 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Bupivacaine
Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.
Drug: Bupivacaine
Abdominal injection of bupivacaine into fascial layer.
Other Name: Marcaine

Experimental: Bupivacaine Liposome
Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.
Drug: Bupivacaine liposome
Abdominal injection of bupivacaine liposome into fascial layer.
Other Name: Exparel




Primary Outcome Measures :
  1. In-hospital Postoperative Opioid Consumption [ Time Frame: up to postoperative day 3 at 1 pm ]
    Daily overall opioid use recorded as morphine equivalents


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: Approximately every 6 hours through postoperative day 3 by 1 pm ]
    Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)

  2. Time to Patient Mobilization [ Time Frame: From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery). ]
    Number of days from day of surgery until patient mobilization

  3. Time to Return of Bowel Function [ Time Frame: From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery). ]
    Number of days from time of surgery until return of bowel function

  4. Time to Clear Liquid Diet [ Time Frame: From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery). ]
    Number of days from time of surgery until patient tolerates clear liquid diet

  5. Time to Low Fiber Diet [ Time Frame: From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery). ]
    Number of days from day of surgery until patient tolerates low fiber diet

  6. Length of Stay [ Time Frame: Date of surgery to date of discharge (usually up to 4 days after surgery). ]
    Total postoperative hospital stay in days

  7. In-hospital Antiemetic Use [ Time Frame: Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery). ]
    Amount of ondansetron patient required postoperatively during hospital stay, in milligrams

  8. Complications [ Time Frame: Within 30 days of surgery ]
    Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery

  9. Readmissions [ Time Frame: Within 30 days of hospital discharge ]
    Patient readmitted to hospital after discharge

  10. Mortality [ Time Frame: Within 30 days of surgery ]
    Patient death after surgery

  11. Hospitalization Costs [ Time Frame: From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery). ]
    Total hospitalization costs per patient per this surgical encounter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery

Exclusion Criteria:

  • Allergic to local anesthetics
  • Unable to provide consent
  • Pregnant
  • On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study)
  • Undergoing emergent operations
  • Undergoing loop ileostomy reversal
  • Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638635


Locations
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United States, Virginia
Fairfax Colon & Rectal Surgery, Alexandria Office
Alexandria, Virginia, United States, 22304
Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office
Fairfax, Virginia, United States, 22031
Fairfax Colon & Rectal Surgery, Fair Oaks Office
Fairfax, Virginia, United States, 22033
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Fairfax Colon & Rectal Surgery, Loudoun Office
Lansdowne Town Center, Virginia, United States, 20176
Fairfax Colon & Rectal Surgery, Reston Office
Reston, Virginia, United States, 20190
Sponsors and Collaborators
Inova Health Care Services
Investigators
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Principal Investigator: Donald Colvin, MD Inova Health Care System
  Study Documents (Full-Text)

Documents provided by Inova Health Care Services:

Publications:

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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT03638635     History of Changes
Other Study ID Numbers: 17-2725
First Posted: August 20, 2018    Key Record Dates
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Inova Health Care Services:
Bupivacaine
Exparel
TAP Block
Opioids
Narcotics
ERAS
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents