Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Change(s) in Post-operative pain
研究概览
简要总结
Patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site. Various graft harvest techniques and methods for post-harvest hemostasis including graft site closure have been explored. Despite the frequency of this clinical scenario there is no established best practice for peri-operative pain management in this patient population. In addition to traditional post operative pain control, groups have sought various peri-operative anesthetic regimens to improve post operative pain. This has led recently to the description of various regional blocks including buccal and periorbital blocks for peri-operative local anesthetic. No study has looked at superiority of regional pain management in this patient population. This study will aim to assess three established anesthetic protocols for oral pain control in a blinded, randomized controlled trial.
Hypothesis: Patients who have buccal block will have lower post op pain without any increase adverse oral outcomes.
详细描述
This is a blinded, randomized, controlled trial following patients undergoing buccal urethroplasty (see criteria). This study will aim to assess three established anesthetic protocols for oral pain control. Each study arm holds equal weight. Approximately 60 subjects will be randomized in a 1:1:1 ratio to receive the following graft harvest techniques, which are all considered standard of care.
Group 1: Current Buccal Harvest
- Infiltration of lidocaine 1% with 1:100,000 epinephrine (maximum 10cc)
- Graft site hemostasis with monopolar cautery
- No suture closure of graft site
Group 2: Basic buccal procedure + Long acting local
- Infiltration of lidocaine 1% with epinephrine (maximum 10cc)
- Graft site hemostasis with monopolar cautery
- No suture closure of graft site
- 0.5% Marcaine (maximum 5cc) at case conclusion
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
Approximately 60 subjects will be randomized in a 1:1:1 ratio to receive 3 different local anesthetic regimens following buccal graft harvest. The care provider administering will not be masked to the type of block, but they will be blinded to the post op outcomes.
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
- •Men, age 18 or older
- •Undergoing anterior urethroplasty with buccal grafting
- •Able to consent
排除标准
- •Taking chronic opiates for pain
- •Diagnosis of chronic pain
- •Prior buccal urethroplasty
- •Vulnerable population (e.g. prisoner)
- •Renal dysfunction or allergy preventing NSAID use
- •Liver dysfunction or allergy preventing Tylenol use
- •Medical allergy to local anesthetic
- •Medical allergy to Peridex/Magic Mouthwash
- •NYHA Class III/IV
- •Hematologic condition that excludes patient from surgery
- •Post-operative complication resulting in inpatient stay
- •Anesthetic complication
- •No buccal site surgical complication
研究组 & 干预措施
Group 1: Standard of care
- Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL
- Routine, standard graft site hemostasis with monopolar cautery
- No suture closure of graft site
- No further infiltration of local anesthetic in mouth
干预措施: Standard Buccal Harvest (Drug)
Group 2: Standard of care + Long acting local
- Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL
- Routine, standard graft site hemostasis with monopolar cautery
- No suture closure of graft site
- Up to a maximum of 10mL of 0.5% bupivacaine infiltration in the buccal graft site
干预措施: Basic buccal procedure + Long acting local (Drug)
Group 3: Standard of care + Buccal block
- Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL
- Routine, standard graft site hemostasis with monopolar cautery
- No suture closure of graft site
- Up to a maximum of 10mL of 0.5% bupivacaine infiltration as a buccal block
干预措施: Basic buccal procedure + Buccal block (Drug)
结局指标
主要结局
Change(s) in Post-operative pain
时间窗: Postoperative Day 1, 5, 10
The Wong-Baker FACES pain scale is a validated scale where a score of 0 is no pain and 10 is the worst pain imaginable. Pain greater than or equal to 5 would result in significant limitations on daily life. Oral, incisional (surgical site), and overall pain will each be assigned a score of 0-10 at each time point (9 total scores).
次要结局
- Change(s) in Post-operative Narcotic use(Postoperative Day 1, 5, 10)