Clinical efficacy of platelet rich plasma and bupivacaine in pain and healing after tonsillectomy . A randomised control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
研究概览
简要总结
The. primary aim of the study,
To evaluate post operative pain score after platelet rich plasma and
bupivacaine injection in tonsillar bed/anterior tonsillar pillar using Visual
analogue score (VAS).
- To evaluate wound healing between the platelet rich plasma and bupivacaine
using a five grade scale based on percentage of slough coverage.
Tonsillectomy remains one of the most frequently performed otolaryngologic operations and
post operative pain and healing remains major problems for the patients.
Pain is due to mucosal injury, muscle injury and exposed cranial nerve endings leading to
inflammation and spasm of pharyngeal musculature. After tonsillectomy high degree of
swelling within 24 hours in uvula and anterior tonsillar pillar and posterior tonsillar pillar may
hinder with healing and is associated with increased post operative complication. It can lead to
decreased oral intake, vomiting, difficulty breathing and dehydration requiring hospital re-admission.
Bupivacaine is a long acting local anaesthetic of the amino amide group. It is indicated for
infiltration anesthesia, nerve block, epidural and intrathecal anesthesia. It can also be used in
surgical area by infiltration or by local application . By blocking the afferent nerve endings
through the inhibition of voltage gated ion channels it decreases the onset of post operative
pain.
Platelet rich plasma (PRP) have been used for various indications for many years, resulting in
interest in potential autologous PRP in regenerative medicine. It is a suitable option with
clinical benefits, with positive clinical outcomes.
PRP which is also known as platelet enriched plasma, platelet rich concentrate, autologous platelet gel and platelet releasate. It is defined as part of plasma fraction of autologous peripheral blood that has a platelet
concentration above baseline. The serum contains epidermal growth factor, tumor growth
factor beta firbronectin, all of which have the property of speeding the process of
epithelisation. It also has antibacterial properties because of immunoglobulin G and lysozyme
ingredients.
The objective of the study is to evaluate the clinical efficacy of PRP and bupivacaine in
reducing postoperative pain and promoting tissue healing following tonsillectomy. By
systematically assessing pain levels and the healing process in the postoperative period, this
study aims to generate evidence that may guide future clinical practice. The results are
expected to help otolaryngologists enhance postoperative care, reduce patient discomfort, and
improve recovery outcomes in individuals undergoing tonsillectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Recurrent sore throat, As per American Academy of Otolaryngology Head and Neck surgery; I.
- •seven or more well-documented clinically significant , adequately treated sore throat in the preceding year, or II.
- •five or more such episodes in each year of the preceding 2 years, or III.
- •three or more such episodes in each of the preceding 3 years.
- •Patient willing to give consent to participate.
排除标准
- •Allergic to bupivacaine
- •Current acute infection or peritonsillar abscess
- •History of palatine tonsils surgery or malignancy
- •Coagulopathy, bleeding disorder, thrombocytopenia
- •Other serious co-morbidity, anaemia, immunodeficiency, hypertensive, Chronic Renal Failure.
- •5.Patients on NSAIDS, anti-coagulants, anti-hypertensive drugs.
研究者
Shivani Thakur
Indira Gandhi Medical College Shimla