Liposomal Bupivacaine To Control Post-Operative Pain Following Buccal Mucosal Graft Harvesting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Morphine equivalent requirements
研究概览
简要总结
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.
详细描述
Pain following urethroplasty with buccal mucosal graft (BMG) harvesting is primarily related to the oral graft harvest site. This pain results in significant increases in narcotic use, patient morbidity, and limits nutritional intake following surgery. During BMG harvesting, lidocaine with epinephrine is routinely injected for hydrodissection and to assist with hemostasis. The analgesic benefits from this local anesthetic, however, have abated prior to completion of the urethral reconstruction and contribute little to post-operative pain control.
In an effort to alleviate pain following BMG harvesting, several centers have evaluated technical aspects of the procedure to reduce post-operative pain. These have primarily focused on location of the graft harvest and wound closure. A novel liposomal formulation of bupivacaine has recently been introduced as a 96-hour delayed release formulation. It has been safely used in multiple surgical wounds and results in significantly reduced post-operative pain and narcotic usage. Given that patient reported pain from the BMG harvest site is worst in the first 1-2 days following surgery, infiltration of this medication has the potential to dramatically reduce post-operative pain in these patients.
Objectives:
Our objective is to evaluate post-operative pain and narcotic usage following BMG harvesting with liposomal bupivacaine infiltration. Our hypothesis is that infiltrating the buccal graft harvest surgical site with liposomal bupivacaine will decrease both post-operative pain and narcotic usage and increase patient satisfaction.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patient blinded for the intraoperative intervention given (With Liposomal Bupivacaine injection to the buccal mucosal graft harvest site or not)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male adults with urethral stricture assessed to be requiring a urethroplasty with BMG harvesting
排除标准
- •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
研究组 & 干预措施
Liposomal Bupivacaine
20ml Liposomal Bupivacaine 1.3% (13.3mg/mL), injected to the buccal mucosal graft harvest site.
干预措施: Liposomal Bupivacaine (Drug)
结局指标
主要结局
Morphine equivalent requirements
时间窗: 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
Incident of oral Morbidities related to the procedure
时间窗: 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
Post-operative Pain score
时间窗: 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)
次要结局
- 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))
- Incident of post-procedural salivary changes(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 taste changes(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 speech changes(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))
- Number of participants with post-procedure full-mouth opening(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))
- Number of participants report perceived adverse effect related to local anesthetics(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))