Inferior Alveolar Nerve Block for Intraoperative Analgesia for Maxillofacial Cancer Surgery Requiring Unilateral Mandibular Resection-A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- IV fentanyl requirement during primary tumour removal
研究概览
简要总结
Mandibular resection which is an important component of maxillofacial cancer surgery is an extremely painful procedure associated with severe sympathetic response needing high doses of opioids. Inferior alveolar nerve block is a common nerve block used by dentists for mandibular dental extractions. The aim of this trial is to study the effect of this block for intraoperative analgesia in maxillofacial cancer surgeries requiring unilateral mandibular resection.
详细描述
All adult patients below 75yrs of age scheduled for maxillofacial surgery will be screened for inclusion and exclusion criteria.
Written informed consent will be taken one day prior to surgery. Consenting subjects will be randomized after induction of anaesthesia to study or control arm.
The duration of the study is from induction of anaesthesia to the completion of primary tumour removal and neck dissection
Study procedure: Ipsilateral Inferior alveolar nerve block A long acting local anaesthetic agent Inj Bupivacaine hydrochloride 0.5% (2 ml) will be given after induction by open mouth technique by landmark method.
The mucobuccal fold will be palpated and traced till coronoid notch. The finger will be moved medially across the retromandibular trigone on internal oblique ridge. The 25G needle will be inserted till bone is felt. 2 ml of 0.5% bupivacaine will be injected slowly after withdrawing needle by 1mm and confirming negative aspiration of blood.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients between the age of 18 and 75 yrs classified as ASA I and II physical status requiring maxillofacial cancer surgery requiring unilateral mandibular resection and unilateral neck dissection
排除标准
- •- surgery involving upper alveolar / maxillary resection
- •patients with BMI below 18kg/m2 and above 30kg/m2
- •allergy to local anaesthetic agent
- •Inability to give inferior alveolar nerve block due to any cause e.g. restricted mouth opening, obscured landmark or infection at site
- •pregnant women
- •patients unable to give valid consent e.g. patients with learning difficulties
- •patients on medications for hypertension
- •patients with preoperative pain requiring regular pain medications
- •uncontrolled haemodynamic status e.g. baseline arterial blood pressure above 160 /90 and baseline HR above 100 /min
结局指标
主要结局
IV fentanyl requirement during primary tumour removal
时间窗: From start to finish ofprimary tumour removal procedure
The total IV fentanyl dose required during primary tumour removal will be noted
次要结局
- IV fentanyl requirement during neck dissection and primary tumour removal(From start to finish of neck dissection and primary tumour removal)
- Maximum change in heart rate from baseline during primary tumour removal(From start to finish of primary tumour removal procedure)
- Maximum change in blood pressure from baseline during primary tumour removal(From start to finish of primary tumour removal procedure)
- Need for rescue analgesics or vasoactive agents during primary tumour removal(From start to finish of primary tumour removal procedure)
研究者
Madhavi Shetmahajan
Associate professor, dept of anaethesia
Tata Memorial Centre