Effect Of Infraalveolar Nerve Block Plus Buccal Nerve Block Plus Local Infiltration Vs Local Infiltration on Post-Operative Pain Scores at Buccal Mucosal Graft Harvest Site: A Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To compare postoperative pain scores amongst patients undergoing buccal mucosal graft harvest under infraalveolar plus buccal nerve block plus local infiltration vs local infiltration.
研究概览
简要总结
BuccalMucosal Graft (BMG) is the most common and versatile graft used for varioustechniques of urological reconstructions. Donor site morbidities have beenstudied previously. (1)Important morbidity of thisprocedure is post operative pain at the harvest site. Significant postoperative pain often hinders resumption of normal oral diet.(2) Various strategies to alleviatepain like infiltration of donor site with various types of local anaestheticsand primary closure of the donor wound have been tried.(3) Primary closure of wound was foundto be inferior to keeping the wound open in terms of post operative pain. (4,5)One study found infraorbital nerveblock to be superior to no block. (6)The combined infraalveolar andbuccal nerve block, which is commonly used in lower jaw dental procedurescovers the area of interest of BMG, but has not been studied in this setting toour knowledge. We aim to compare its efficacy with respect to the currentstandard of care (SOC) of local anaesthetic infiltration. If significantimprovement is detected as hypothesized, the usage of nerve blocks during BMGharvest might become the new standard of care.
References:
1. Markiewicz MR, DeSantis JL, MargaroneJE, Pogrel MA, Chuang SK. Morbidity Associated With Oral Mucosa Harvest forUrological Reconstruction: An Overview. Journal of Oral and MaxillofacialSurgery. 2008 Apr;66(4):739–44.
2. Wood DN, Allen SE, Andrich DE, GreenwellTJ, Mundy AR. The morbidity of buccal mucosal graft harvest for urethroplastyand the effect of nonclosure of the graft harvest site on postoperative pain. JUrol. 2004 Aug;172(2):580–3.
3. Chua ME, Zuckerman JM, Strehlow R,Virasoro R, DeLong JM, Tonkin J, et al. Liposomal Bupivacaine LocalInfiltration for Buccal Mucosal Graft Harvest Site Pain Control: ASingle-blinded Randomized Controlled Trial. Urology. 2020 Nov;145:269–74.
4. Rourke K, McKinny S, St Martin B.Effect of wound closure on buccal mucosal graft harvest site morbidity: resultsof a randomized prospective trial. Urology. 2012 Feb;79(2):443–7.
5. Soave A, Dahlem R, Pinnschmidt HO, RinkM, Langetepe J, Engel O, et al. Substitution Urethroplasty with Closure VersusNonclosure of the Buccal Mucosa Graft Harvest Site: A Randomized ControlledTrial with a Detailed Analysis of Oral Pain and Morbidity. Eur Urol. 2018Jun;73(6):910–22.
6. Jonnavithula N, Bachu D, Sriramoju V,Devraj R, Gunta R, Pisapati MurthyVLN. Effect of infraorbital nerve block onpostoperative pain and 30-day morbidity at the donor site in buccal mucosalgraft urethroplasty. J Anaesthesiol Clin Pharmacol. 2019;35(1):114.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 years or above undergoing Buccal Mucosal Graft harvest for any indication.
排除标准
- •Patients not giving consent
- •Patients with oral sub mucosal fibrosis
- •Active smokers
- •Patients with known drug allergy to local anesthetic drugs
- •Patients with severe cardiovascular compromise.
结局指标
主要结局
To compare postoperative pain scores amongst patients undergoing buccal mucosal graft harvest under infraalveolar plus buccal nerve block plus local infiltration vs local infiltration.
时间窗: immediate post-operative period, 2 hrs, 4 hrs, 6 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 5 dats, 7 days
次要结局
- a)To compare time to resumption of pain free oral liquid intake amongst patients undergoing buccal mucosal graft harvest under infraalveolar plus buccal nerve block plus local infiltration vs local infiltration(immediate post-operative period, 2 hrs, 4 hrs, 6 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 5 dats, 7 days)
- b)To compare time to resumption of pain free oral solid intake amongst patients undergoing buccal mucosal graft harvest under infraalveolar plus buccal nerve block plus local infiltration vs local infiltration(immediate post-operative period, 2 hrs, 4 hrs, 6 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 5 dats, 7 days)
- c)To compare the incidence of postoperative complications: oral numbness, scarring, contracture, dry mouth at 1 month follow-up amongst patients undergoing buccal mucosal graft harvest under infraalveolar plus buccal nerve block plus local infiltration vs local infiltration(immediate post-operative period, 2 hrs, 4 hrs, 6 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 5 dats, 7 days)
- d) To assess correlation between size of BMG harvested and post operative pain.(On the day of surgery)