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临床试验/CTRI/2024/04/065343
CTRI/2024/04/065343已完成3 期

A Randomised controlled study for efficacy of bilateral transverse thoracis muscle plane block on perioperative requirement of fentanyl in patients undergoing cardiac surgery

Department of Anesthesiology and Critical Care SMS Medical College and Attached Hospitals Jaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月15日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Mean Dose of Fentanyl Intraoperative and postoperative period

研究概览

简要总结

At the time of pre-operative visit, patients will be familiarised with the procedure, a 11 point Numeric

Rating Scale (NRS) for pain assessment (0 = no pain at all, 10 = worst imaginable pain) and use of PCA

pump.On arrival to the operation theatre, fasting status, written informed consent and PAC will be checked.

All routine monitors will be attached; HR, SBP, DBP, MAP, ECG and Spo2 will be noted. Intravenous line

with 18G cannula will be secured and i.v. fluid RL will be started at 5ml/kg/hour.

Internal jugular vein (IJV) and femoral arterial cannulation will be done under local anesthesia.

Patient will be induced with Inj. Midazolam i.v. (0.05mg/kg), Inj. Fentanyl i.v. (3/ μgkg), Inj.Etomidate i.v.

(0.3mg/kg), Inj. Rocuronium i.v. (0.9mg/kg) will be given as a muscle relaxant to facilitate endotracheal

intubation. Patient will be ventilated with 100% oxygen for 3 minutes and under direct laryngoscopy patient

will be intubated with the appropriate size E.T.T. Bilateral air entry will be checked and tube will be fixed.

ULTRASOUND GUIDED BLOCKS: TTMPB will be performed in supine position under sterile conditions after patient is anaesthetised before the commencement of the surgical procedure. A high

frequency 12 MHz linear ultrasound probe with a sterile sheath placed 1 cm lateral to the sternal border, T4-T5 intercostal space identified under ultrasound guidance in a parasagittal view and needle inserted in plane to the probe.

Transversus Thoracis Muscle Plane block will be performed in patients of Group A at T4-T5 intercostal space bilaterally with a 22G atraumatic spinal needle using 40ml 0.5% Ropivacaine with adjuvant Fentanyl 20 mcg (20 ml each side) 10 ml of 0.5 % Ropivacaine is infilterated around the pleural chest tube sites in both the groups . Heart rate, Systolic, Diastolic and mean Blood pressure and CVP will be recorded preoperatively as baseline, just after block, 5 min after block, just after intubation, 5 min after intubation and every 15 min thereafter.

The surgery will be allowed to commence and anesthesia will be maintained will 100% oxygen, 1%

sevoflurane and intermittent Inj. Vecuronium i.v. (0.01mg/kg/half an hourly), injection midazolam 0.01mg/kg hourly , The BIS guided monitoring will be used to evaluate intraoperative pain, BIS monitoring measures the depth of anesthesia and facilitates anesthetic titration, BIS will be maintained 40-60 during surgery if score more than 60 injection Fentanyl 1mcg/kg IV dose will be repeated .

Total intraoperative Fentanyl will be noted.

Patient will be shifted to ICU with IPPV and taken on ventilator. As per protocol of our hospital injection paracetamol 1 gm IV will be given before patient is shifted to ICU.

When patient is conscious, hemodynamically stable and fulfills the criteria of extubation, the patient will be, the time of extubation will be noted.

After extubation, NRS (Numeric Rating Scale) pain score will be noted.

In ICU, Patient Controlled Analgesia (PCA) pump will be started with Fentanyl (5 mcg/ml) at a basal infusion rate of 2 ml/hr and a bolus 2ml (10 mcg) whenever needed by the patient him/herself with a lockout

interval of 15 mins upto 48 hours after extubation. If patient needs rescue analgesia within lockout interval Inj Tramadol (50mg) IV bolus will be given.

H0 (NULL HYPOTHESIS):

There is no significant difference in the mean of total dose requirement of Fentanyl in 48 hours with Transverse Thoracis Muscle Plane Block (TTMPB) as compared to the control group.

H1 (ALTERNATE HYPOTHESIS):

There is a significant difference in the mean of total dose requirement of Fentanyl in 48 hours with TTMPB as compared to the control group.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patient undergoing planned cardiac surgery via median sternotomy, patient giving informed consent for study, weight 40 to 75 kg, ASA PS grade 2 or 3.

排除标准

  • Patient undergoing CABG using Internal Mammary Artery, Non-consenting patient, patient should not be a part of other study, allergic to study drugs, endocrine, metabolic, neurological and psychiatric disorders, patients on anti coagulant drugs or coagulopathy.

结局指标

主要结局

Mean Dose of Fentanyl Intraoperative and postoperative period

时间窗: At end of surgery, 48 hours postoperative

次要结局

  • Mean Hemodynamic Variables - mean heart rate, mean systolic, diastolic and mean blood pressures(Pre operative, 2 mins after intubation, 2 mins after TTMB, 15 min, 30 min, every 15 mins till patient goes on Cardiopulmonary bypass, 0 mins after coming off pump, every 15 mins till surgery is complete. Immediate Post operative, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs)
  • Mean PEFR at time of extubation(At time of extubation)

研究者

发起方
Department of Anesthesiology and Critical Care SMS Medical College and Attached Hospitals Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anjum Saiyed

SMS Medical College and Attached hospitals

研究点 (1)

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