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临床试验/NCT05090579
NCT05090579尚未招募不适用

Nalgesic Effect of Nulbuphine-bupivacaine Combination in Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Major Abdominal Cancer Surgeries .

Assiut University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
time of request of first analgesia

研究概览

简要总结

To compare the analgesic effect of two different doses of nulbuphine (10 mg and 20 mg) added to bupivacaine in bilateral subcostal single injection in ultrasound-guided TAP block for abdominal surgeries.

详细描述

The ultrasound-guided TAP block will be performed before the induction of general anesthesia. Upon arrival at the operating room, the patients will be place in the supine position and an 18-gauge intravenous (IV) cannula will be inserted for IV fluid and drug administration. Basic monitoring probes (electrocardiography, non-invasive blood pressure, oxygen saturation, and temperature) will be applied, and their baseline vital signs will be recorded. Lactated Ringer's solution 10mL/ kg will be infused intravenously over 10 minutes before the initiation of the TAP block.

The TAP block will be performed with the use of ultrasound, under complete aseptic technique. A broadband linear array probe will be used with an imaging depth of 4 - 6 cm. The ultrasound probe will be placed transversely to the abdomen (horizontal plane) in the midaxillary line between the costal margin and the iliac crest. Three muscle layers are clearly seen in the image. The needle (22-gauge x 80 mm SonoPlex stim cannula, Pajunk®, Geisingen, Germany) will be inserted in a sagittal plane approximately 3 - 4 cm medial to the ultrasound probe. The point of needle insertion will be closer to the probe. For optimal imaging of the needle, it will be held parallel to the long axis of the probe (in-line view). The needle tip will be directed into the plane below the internal oblique and above the transversus abdominis muscle. A small volume of local anesthetic (2 mL) was seen to open the plane between the 2 muscles and was followed by insertion of the full dose of local anesthetic. If the 2 mL dose appears to be within the muscle rather than between them, then needle adjustment will be required. The local anesthetic injected appeared hypoechoic (black compared to the muscle layers) on ultrasound image.

The TAP block will be performed with the use of ultrasound under complete aseptic technique. A broadband linear array probe will be used with an imaging depth of 4 - 6 cm using a 22-gauge × 80 mm SonoPlex stim cannula (Pajunk®, Geisingen, Germany). Twenty minutes after the TAP block, the extent of sensory blockade will be evaluated by using the pin prick test (0 = no block, 1 = hyposthesia, and 2 = anesthesia) by another blinded attending anesthetist. Any patients with a failed block will be excluded from the studied groups.

Anesthetic Technique:

The anesthetic technique will be standardized in the 3 groups. No preoperative analgesics will be given. After a successful TAP block, ?? general anesthesia will be induced intravenously (propofol 1 - 2 mg/kg, lidocaine 1.5 mg/ kg) and fentanyl 1 μg/kg. Endotracheal intubation will be facilitated by neuromuscular blockade with cisatracurium 0.3 mg/kg. Anesthesia and muscle relaxation will be maintained with isoflurane in an air/oxygen mixture and cisatracurium 0.15 mg/kg. The patients will be mechanically ventilated in parameters that maintain the end-tidal CO2 (ETCO2) between 33 and 36 mmHg. The patients' heart rate, oxygen saturation, ETCO2, and systolic and diastolic blood pressures will be measured and recorded. Hypotension will be defined as a 15% decrease in systolic blood pressure from the base line, bradycardia as a heart rate slower than 50 beats per minute, and hypoxia as an oxygen saturation less than 90%. Hypotension will be treated with intravenous boluses of ephedrine 0.1 mg/kg, repeated as required. Bradycardia will be treated with intravenous atropine 0.01 mg/kg.

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
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA classification I-ll,
  • Aged >18 years,
  • weight 50-85 kg,
  • Patients who will undergo abdominal cancer surgery.

排除标准

  • Patient's refusal,
  • patients with a history of allergies to studied drugs,
  • Patients with coagulation disorders,
  • Patients with opioid dependence,
  • Patients with morbid obesity (body mass index more than 40 kg/m2),
  • Patients with sepsis,
  • patients with psychiatric illnesses that will interfere with the perception and assessment of pain .

结局指标

主要结局

time of request of first analgesia

时间窗: Time Frame: 24 hours post-operatively ]

VAS (Visual Analogue Scale, 0-100 mm; where 0 = no pain, and 100 = worst imaginable pain) will be assessed, at rest, per hour for 24 hours post operatively. Moreover, VAS will also be assessed at 12 and 24 hours post-operatively while abducting the ipsilateral arm. If the patient experiences a pain of \> 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3. Time which will pass until the request of first analgesia shall be determined for each group and compared.

次要结局

  • total morphine consumption in the first 24 hours postoperatively(Time Frame: 24 hours post-operatively ])

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Muhammed Othman

Resident

Assiut University

研究点 (1)

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