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Liposomal Bupivacaine To Control Post-Operative Pain Following BMG

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ClinicalTrials.gov Identifier: NCT03720223
Recruitment Status : Unknown
Verified October 2018 by Urology of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : October 25, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Urology of Virginia

Brief Summary:
This is a single blinded-randomized controlled trial that recruit male patients for substitution urethroplasty using buccal mucosal graft. The study investigators aim to assess the efficacy and safety of liposomal bupivacaine injection to the buccal graft harvest site on post-operative main score, morphine equivalence requirement and oral morbidities.

Condition or disease Intervention/treatment Phase
Urethral Stricture Drug: Liposomal Bupivacaine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Patient blinded for the intraoperative intervention given (With Liposomal Bupivacaine injection to the buccal mucosal graft harvest site or not)
Primary Purpose: Treatment
Official Title: Liposomal Bupivacaine To Control Post-Operative Pain Following Buccal Mucosal Graft Harvesting
Actual Study Start Date : January 20, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

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Arm Intervention/treatment
Experimental: Liposomal Bupivacaine
20ml Liposomal Bupivacaine 1.3% (13.3mg/mL), injected to the buccal mucosal graft harvest site.
Drug: Liposomal Bupivacaine
20ml of Liposomal Bupivacaine 1.3% (13.3mg/mL)
Other Name: Exparel

No Intervention: Control
No local anesthetics injected to the buccal mucosal graft harvest site



Primary Outcome Measures :
  1. Post-operative Pain score [ Time Frame: Post-op day 1 ]
    Continuous variables to be assessed as: Post-operative oral pain score measured using 10 point visual analogue score for pain assessment (minimum 0 or no pain to maximum 10 most painful)

  2. Morphine equivalent requirements [ Time Frame: Post-procedure day 1 ]
    Continuous variable to be assessed as : Narcotics requested by the patient and administered post-procedural day 1 and day 2 (Total and separately assessed). All narcotics will be converted to IV morphine equianalgesic equivalent conversion factors according to American Pain Society

  3. Morphine equivalent requirements [ Time Frame: post-procedure day 2 ]
    Continuous variable to be assessed as : Narcotics requested by the patient and administered post-procedural day 1 and day 2 (Total and separately assessed). All narcotics will be converted to IV morphine equianalgesic equivalent conversion factors according to American Pain Society

  4. Incident of oral Morbidities related to the procedure [ Time Frame: intraoperative up to 1 month post-procedure ]
    Event rate nominal variable to be assessed as: oral morbidity post-procedure categorized according to Clavien Dindo-Classification


Secondary Outcome Measures :
  1. Post-operative Pain score [ Time Frame: Post-op day 2 ]
    Continuous variables to be assessed as: Post-operative oral pain score measured using 10 point visual analogue score for pain assessment (minimum 0 or no pain to maximum 10 most painful)

  2. Post-operative Pain score [ Time Frame: Post-op day 3 ]
    Continuous variables to be assessed as: Post-operative oral pain score measured using 10 point visual analogue score for pain assessment (minimum 0 or no pain to maximum 10 most painful)

  3. Post-operative Pain score [ Time Frame: Post-op day 1 month follow-up ]
    Continuous variables to be assessed as: Post-operative oral pain score measured using 10 point visual analogue score for pain assessment (minimum 0 or no pain to maximum 10 most painful)

  4. number of participants with return to regular diet post-procedure [ Time Frame: Post-op day 1- 3, then 1 month follow-up (Optional daily up to post-op day 7 and monthly after 1 month up to one year or beyond) ]
    Event rate nominal variable to be assessed using survey question (yes or no)

  5. Incident of post-procedural peri-oral numbness [ Time Frame: Post-op day 1- 3, then 1 month follow-up (Optional daily up to post-op day 7 and monthly after 1 month up to one year or beyond) ]
    Event rate nominal variable to be assessed using survey question (yes or no)

  6. Incident of post-procedural salivary changes [ Time Frame: Post-op day 1- 3, then 1 month follow-up (Optional daily up to post-op day 7 and monthly after 1 month up to one year or beyond) ]
    Event rate nominal variable to be assessed using survey question (more, less or none)

  7. Incident of post-procedural taste changes [ Time Frame: Post-op day 1- 3, then 1 month follow-up (Optional daily up to post-op day 7 and monthly after 1 month up to one year or beyond) ]
    Event rate nominal variable to be assessed using survey question (yes or no)

  8. Incident of post-procedural speech changes [ Time Frame: Post-op day 1- 3, then 1 month follow-up (Optional daily up to post-op day 7 and monthly after 1 month up to one year or beyond) ]
    Event rate nominal variable to be assessed using survey question (yes or no)

  9. Number of participants with post-procedure full-mouth opening [ Time Frame: Post-op day 1- 3, then 1 month follow-up (Optional daily up to post-op day 7 and monthly after 1 month up to one year or beyond) ]
    Event rate nominal variable to be assessed using survey question (yes or no)

  10. Number of participants report perceived adverse effect related to local anesthetics [ Time Frame: Post-op day 1- 3, then 1 month follow-up (Optional daily up to post-op day 7 and monthly after 1 month up to one year or beyond) ]
    Event rate nominal variable to be assessed using survey question (yes or no)



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

Inclusion Criteria:

  • male adults with urethral stricture assessed to be requiring a urethroplasty with BMG harvesting

Exclusion Criteria:

  • female adult patient with urethral strictures
  • prior diagnosis of chronic pain or systemic disease that would interfere with outcome assessment or metabolism of the local anesthetics or narcotics.
  • allergy to liposomal content or bupivacaine or any cross reaction to local anesthetics
  • neurological disease with impaired communication or neurological deficit to pain
  • with poor oral health with lesions
  • urethroplasties with no requirement for BMG graft
  • on daily narcotic requirement pre-operatively
  • on daily analgesia medication required for other condition
  • consented for other clinical trials which may interfere the outcome assessment
  • unwilling for post-operative interview or survey involvement

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): NCT03720223


Locations
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United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
Urology of Virginia
Investigators
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Principal Investigator: Kurt McCammon, MD FACS Eastern Virginia Medical School- Urology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Urology of Virginia
ClinicalTrials.gov Identifier: NCT03720223    
Other Study ID Numbers: 14-09-FB-0185
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
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.: Yes
Keywords provided by Urology of Virginia:
Buccal mucosal graft
Additional relevant MeSH terms:
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Urethral Stricture
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents