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Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane (Exparel)

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: NCT04005859
Recruitment Status : Active, not recruiting
First Posted : July 2, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin Kasten, Atrium Health

Brief Summary:
To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and quality of life on follow up.

Condition or disease Intervention/treatment Phase
Colorectal Disorders Drug: Exparel Drug: IV Lidocaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : February 22, 2020
Estimated Study Completion Date : February 22, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CONTROL: IV Lido
CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)
Drug: IV Lidocaine

1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35

  1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
  2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
  3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.

Experimental: EXPERIMENTAL: Exparel
EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)
Drug: Exparel

2. Liposomal bupivacaine TAP block (experimental arm) n= 35

  1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
  2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
  3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
  4. Adhesive tapes will be applied at the level of the TAP block puncture sites.




Primary Outcome Measures :
  1. Change in Verbal Pain Scale (VRS) [ Time Frame: every 6 hours postoperatively for the first 24 hours, then at least every 6 hours as per standard nursing protocol with vital signs and administration of pain medications. Additionally at 2 and 4 weeks from discharge. ]
    postoperative pain as measured by verbal rate scale (VRS) Scale of 0-10. The scale measures pain amount on a scale of 1-10 under the following scenarios: pain right now, pain at rest, and pain while active. The scale ranges from 1 'no pain' to 10 'worst possible, unbearable, excruciating pain.' The scale is measured by taking the individual scores of the three conditions mentioned. Then, we look at how each of those three conditions change over time. Subscales are scored separately and we do not average scores.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-75 years
  • Elective laparoscopic colorectal surgery
  • ASA I-III

Exclusion Criteria:

  • Contraindication to Na Channel Blocker
  • Chronic Opioid use
  • Liver dysfunction
  • Renal insufficiency
  • Epilepsy
  • Psychomotor retardation
  • BMI >40
  • Sleep Apnea
  • Cardiac Rhythm Disorders
  • Planned open or concomitant procedure

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): NCT04005859


Locations
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United States, North Carolina
Carolinas Medical Center - Atrium Health
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Atrium Health
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Responsible Party: Kevin Kasten, Associate Professor and Physician, Colon and Rectal Surgery, Atrium Health
ClinicalTrials.gov Identifier: NCT04005859    
Other Study ID Numbers: 01-18-16
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

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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
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action