Liposomal Bupivacaine To Control Post-Operative Pain Following BMG
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedFirst Submitted
Initial submission to the registry
October 22, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedOctober 1, 2021
September 1, 2021
2.8 years
October 22, 2018
September 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Post-operative Pain score
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)
Post-op day 1
Morphine equivalent requirements
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
Post-procedure day 1
Morphine equivalent requirements
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
post-procedure day 2
Incident of oral Morbidities related to the procedure
Event rate nominal variable to be assessed as: oral morbidity post-procedure categorized according to Clavien Dindo-Classification
intraoperative up to 1 month post-procedure
Secondary Outcomes (10)
Post-operative Pain score
Post-op day 2
Post-operative Pain score
Post-op day 3
Post-operative Pain score
Post-op day 1 month follow-up
number of participants with return to regular diet post-procedure
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)
Incident of post-procedural peri-oral numbness
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)
- +5 more secondary outcomes
Study Arms (2)
Liposomal Bupivacaine
EXPERIMENTAL20ml Liposomal Bupivacaine 1.3% (13.3mg/mL), injected to the buccal mucosal graft harvest site.
Control
NO INTERVENTIONNo local anesthetics injected to the buccal mucosal graft harvest site
Interventions
20ml of Liposomal Bupivacaine 1.3% (13.3mg/mL)
Eligibility Criteria
You may qualify if:
- male adults with urethral stricture assessed to be requiring a urethroplasty with BMG harvesting
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology of Virginia
Virginia Beach, Virginia, 23454, United States
Related Publications (1)
Chua ME, Zuckerman JM, Strehlow R 6th, Virasoro R, DeLong JM, Tonkin J, McCammon KA. Liposomal Bupivacaine Local Infiltration for Buccal Mucosal Graft Harvest Site Pain Control: A Single-blinded Randomized Controlled Trial. Urology. 2020 Nov;145:269-274. doi: 10.1016/j.urology.2020.06.067. Epub 2020 Jul 18.
PMID: 32692990DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kurt McCammon, MD FACS
Eastern Virginia Medical School- Urology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Patient blinded for the intraoperative intervention given (With Liposomal Bupivacaine injection to the buccal mucosal graft harvest site or not)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2018
First Posted
October 25, 2018
Study Start
January 20, 2015
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
October 1, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share