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临床试验/CTRI/2025/04/084004
CTRI/2025/04/084004招募中2/3 期

USG guided Suprazygomatic Maxillary nerveblock vs parenteral analgesics in patients undergoing maxillary surgeries :Prospective Randomized Control Trial

Department of Anaesthesiology,Pain Medicine and Critical Care1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年4月25日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
26
试验地点
1
主要终点
Total amount of intra operative analgesic requirement

研究概览

简要总结

Title : ’USG GUIDED SUPRAZYGOMATIC MAXILLARY NERVE BLOCK  VS PARENTERAL ANALGESICS FOR INTRAOPERATIVE AND POSTOPERATIVE PAIN RELIEF IN MAXILLARY SURGERY :A PROSPECTIVE RANDOMISED CONTROL TRIAL ’

PRIMARY OBJECTIVES

Total amount of intra operative analgesic requirement ( iv fentanyl -mcg/kg)in patients receiving the block compared to controls receiving parenteral analgesics .

SECONDARY OBJECTIVE

1)Time to first rescue analgesic (iv ketorolac) (mins/hrs)

  1. Post operative analgesic requirement (upto 24hrs)

  2. Intra operative and post operative hemodynamics(Heart rate, Mean arterial pressure, Systolic and Diastolic Blood Pressure, Oxygen saturation)

  3. Adverse events if any

INCLUSION CRITERIA

●Age -18 to 65 years of age

●Patients posted exclusively for maxillary surgeries

●Patients giving consent

●ASA PS 1 and 2

EXCLUSION CRITERIA

●Patients with hemangioma or vascular tumours around the injection site

●Patients with any local site infection

●Patients with deranged coagulation profile

●Patients with decreased IQ or Mental retardation

●Patients with local anesthetic allergy or contraindication to any of the study drugs

●Patients with difficult anatomy around the injection site (eg :Tmj Ankylosis)

All the selected patients will undergo a routine pre-anesthetic assessment one day prior to surgery. Patients will also be made familiar with the NRS scoring system. The patient information sheet will be provided to all, and informed written consent from all patients will be obtained.

Standard fasting guidelines(WHO) will be followed for all patients.

In the operating room, standard monitoring will be done as per Anesthesiologists’(ASA) recommendation (3-Lead ECG, pulse oximetry,NIBP)will be initiated and baseline vitals -Heart rate (HR), systolic BP (BP), diastolic BP (DBP), mean arterial pressure (MAP) will be recorded.An 18G intravenous cannula will be secured preoperatively.Patients will be placed in a supine position with their heads elevated with a pillow approximately 15 degrees.Baseline vitals will be recorded. Preoxygenation will be done with FiO2 100% and flow of 5L/min till the end tidal oxygen fraction is higher than 90% induction with intravenous (IV) Fentanyl 2mcg/Kg, followed by IV Propofol 2mg/Kg will be done followed by nasotracheal intubation with appropriate size endotracheal tube.IV Atracurium at a dose of 0.5mg/Kg will be given as relaxant and timer will be started accordingly. Patients belonging to both groups received standard general anesthesia.

INTERVENTION-

Group C(Control group)- will receive parenteral analgesics ( IV acetaminophen, fentanyl 0.5mcg/kg)

Group I(Intervention group)- will receive by suprazygomatic maxillary nerve block under USG guidance with

0.25% bupivacaine + clonidine 1mcg/kg and parenteral analgesics (IV acetaminophen, fentanyl0.5 mcg/kg)

During intraoperative period, iv fentanyl will be given as rescue analgesic whenever Heart rate and Systolic Blood Pressure rise more than 20 percent of baseline values , after ensuring adequate muscle relaxation.

Patients will be maintained with mixture of oxygen and Air(50:50) with isoflurane with a MAC of 0.8-1.0 .

All patients will receive IV dexamethasone as 0.2mg/kg for prevention of intra oral edema which is a standard protocol of our Institute.

Reversal of anaesthesia (with neostigmine and glycopyrrolate)will be as per standard protocol.

POSTOPERATIVE PERIOD:

Patients will be managed in the post operative care unit (PACU) where the standard monitoring of oxygen saturation (SpO2), Heart rate (HR) and non invasive blood pressure monitoring will be done every 10 minutes till 2 hours being shifted to ward and postoperative outcomes are simultaneously assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients posted exclusively for maxillary surgeries 2.Patients giving consent 3.ASA PS 1 and 2.

排除标准

  • 1.Patients with hemangioma or vascular tumours around the injection site 2.Patients with any local site infection 3.Patients with deranged coagulation profile 4.Patients with decreased IQ or Mental retardation 5.Patients with local anesthetic allergy or contraindication to any of the study drugs ●Patients with difficult anatomy around the injection site (eg :Tmj Ankylosis).

结局指标

主要结局

Total amount of intra operative analgesic requirement

时间窗: Till the end of surgery

( iv fentanyl -mcg/kg)in patients receiving the block compared to controls receiving parenteral analgesics .

时间窗: Till the end of surgery

次要结局

  • 1)Time to first rescue analgesic (iv ketorolac) (mins/hrs)(2) Post operative analgesic requirement (upto 24hrs))

研究者

发起方
Department of Anaesthesiology,Pain Medicine and Critical Care
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Devalina Goswami

All India Institute of Medical Sciences

研究点 (1)

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