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QL Block With Exparel in Colectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827291
Recruitment Status : Suspended (COVID-19 Hold)
First Posted : February 1, 2019
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to determine if using a different type of injection of local anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a quadratus lumborum block) will improve pain control and be easier to manage after surgery than the current standard of care epidural (spinal injection) pain relief for patients undergoing laparoscopy colectomy.

Condition or disease Intervention/treatment Phase
Laparotomy Colectomy Drug: Exparel Other: Thoracic epidural analgesia Phase 4

Detailed Description:

Participants in this study will receive exparel via an abdominal muscle nerve block procedure immediately prior to their operation. Participants will be in this study for 96 hours following surgery, which is typically 3 days. During participation, the study staff will review participant's electronic health records for pain scores and pain medication needs.

Participants that receive the quadratus lumborum block, may experience improved pain control and/or reduced side effects compared to the epidural pain relief option, but it is not known yet whether this will be the case.

The most common risk is being sore in the flank where the block was placed. Other risks of the block rarely occur (less than .5-1%), these can include infection, allergy to the local anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac arrest.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Compare efficacy of a quadratus lumborum block performed with liposomal bupivacaine for pain relief after laparoscopic colectomy compared to a historical cohort who received thoracic epidural analgesia.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quantitative Observational Comparative Effectiveness of Quadratus Lumborum (QL) Block With Liposomal Bupivacaine (Exparel®) Versus Thoracic Epidural Analgesia in Patients Undergoing Laparoscopic Colectomy.
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 8, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Quadratus lumborum block
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Drug: Exparel
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.

Thoracic epidural analgesia
Historical cohort that received thoracic epidural analgesia.
Other: Thoracic epidural analgesia
Historical cohort that received thoracic epidural analgesia




Primary Outcome Measures :
  1. Cumulative opioid consumption over 48 hours [ Time Frame: Opioid consumption from administration of Exparel to 48 hours post-administration ]
    Opioid consumption from administration of Exparel to 48 hours post-administration


Other Outcome Measures:
  1. 11-point Numeric Rating Scale (NRS-11) [ Time Frame: 30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration ]
    Two measures will be taken with each assessment, one at rest and one with coughing. (11-point scale: 10=worst pain imaginable, 0= no pain)

  2. Block success [ Time Frame: 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration ]
    Presence of demonstrable sensory block over 4 points on the abdomen (one in each of the 4 quadrants), as tested by response to pinprick. Subjects will be asked to report whether the stimulus feels "sharp" or "dull", indicating block failure and success respectively.

  3. Adverse Events [ Time Frame: From administration of Exparel through 168 hours post Exparel administration ]
    Subjects will be evaluated for potential adverse events related to the block including evidence of hematoma, infection, unexpected sensory or motor deficit, local anesthetic systemic toxicity, as well as transient weakness of the hip flexor muscles (a known possible side-effect of QL block).

  4. Satisfaction with postoperative pain control [ Time Frame: From administration of Exparel through 48 hours post Exparel administration ]
    Overall subject satisfaction with pain control will be recorded on postoperative day 0 and 1 (11-point scale: 10=highly satisfied, 0=completely unsatisfied)

  5. Hospital length of stay [ Time Frame: From administration of Exparel through hospital discharge ]
    Measured both by raw length of stay and by time to achieving "discharge readiness", defined by the presence of 3 criteria: a pain score of 3 or less with ambulation, no opioids required in the preceding 6 hours, and the ability to perform self-care (go to the toilet, dress, and shower).

  6. Incidence of opioid-related adverse events [ Time Frame: From administration of Exparel through 168 hours post Exparel administration ]
    Incidence of nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression

  7. Time to first mobilization [ Time Frame: From time of arrival in PACU through first mobilization ]
    Time to first mobilization

  8. Cost [ Time Frame: From time of arrival in PACU through 96 hours post Exparel administration ]
    Hospital costs including pharmacy-related costs, costs due to opioid-related adverse events, the cost associated with nursing interventions and drugs to treat opioid-related adverse events, and overall hospital admission costs will be calculated.

  9. Sleep Quality [ Time Frame: From administration of Exparel through 168 hours post Exparel administration ]
    Two measures will be taken for sleep quality assessment. How much did pain interfere with falling asleep ( 0= no interference, 10= completely interferes). How much did pain interfere with staying asleep (0= no interference, 10= completely interferes). Measures will be taken once daily from POD 1 to POD 7 (approximately 168hrs. after surgery).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for elective, laparoscopic colonic resection by one of three surgeons: Drs. Thacker, Mantyh or Migaly. These surgeons perform this procedure in the same manner
  • Age 18-85 years
  • American Society of Anesthesiologists (ASA) Physical Class I-III
  • BMI 18-35 kg/m^2

Exclusion Criteria:

  • Inability to consent
  • Inability to speak English
  • Pregnancy
  • Emergency surgery
  • Contraindications to regional blockade: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
  • Allergies/intolerances/contraindications to any of the multimodal agents (acetaminophen, gabapentin, ketorolac)
  • Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
  • History of drug or alcohol abuse
  • Rheumatoid arthritis
  • Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments of compliance

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): NCT03827291


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Pacira Pharmaceuticals, Inc
Investigators
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Principal Investigator: Amanda Kumar, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03827291    
Other Study ID Numbers: PRO00091425
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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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.: Yes