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Comparison Between Two Different Doses of Nulbuphine _bupivacaine in TAP Block in Cancer Abdominal Surgeries

2021年10月11日 更新者:Amira Muhammed Othman、Assiut University

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

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.

調査の概要

詳細な説明

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.

At the end of surgery, muscle relaxation will be reversed by neostigmine 50 μg/kg and atropine 10 μg/ kg. The patients will be extubated and transferred to the post-anesthesia care unit (PACU), where they will be monitored for vital signs (heart rate, non-invasive blood pressure, respiratory rate, and O2 saturation) immediately postoperatively and at 2, 4, 6, 12, 18, and 24 hours postoperatively.

The severity of pain and the presence of nausea, vomiting, and respiratory depression will be assessed postoperatively at 0, 2, 4, 6, 12, 18 and 24 hours. The severity of pain will be assessed using a 10 cm VAS at rest and coughing (0 = no pain and 10 = worst imaginable pain). Repiratory function : FVC, FEV and FEV1 /FVC ratio will be recorded postoperatively and 6,12,&24 hr. Postoperatively. If a patient's VAS score was ≥ 3, morphine will be administered intravenously by a dose of 0.05 mg/kg at 15minute intervals until complete pain relief will be achieved. Morphine administration will be ceased when the VAS score at rest and coughing was < 3 on assessment or when over-sedation or respiratory depression will occur (a respiratory rate of < 10 bpm). Rescue antiemetic will be given in the form of ???metoclopramide 10 mg (Zofran 4mg) IV when patients complained of nausea or vomiting.???? (Our primary outcome measure will be total morphine consumption in the first 24 hours postoperatively; our secondary outcome measures will be the postoperative VAS scores, the time of the first request of rescue analgesia (calculated from the time of the TAP block application), spirometry lung function testing and the incidence of postoperative side effects)

研究の種類

介入

入学 (予想される)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:-

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

Exclusion Criteria:-

  • 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 .

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Group I (BN10)
patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine , 1 mL of 10 mg of nulbuphine plus 4 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall.
patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine, 1 mL of 10 mg of nalbuphine plus 4 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall
アクティブコンパレータ:Group II (BN20)
patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine ,2 mL of 20 mg of nulbuphine plus 3 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall.
patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine, 2 mL of 20 mg of nalbuphine plus 3 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall
アクティブコンパレータ:Group lll(B)
patients will receive 20 mL of 0.25%bupivacaine plus 5 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall.
patients will receive 20 mL of 0.25%bupivacaine plus 5 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
time of request of first analgesia
時間枠: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.
Time Frame: 24 hours post-operatively ]

二次結果の測定

結果測定
メジャーの説明
時間枠
total morphine consumption in the first 24 hours postoperatively
時間枠:Time Frame: 24 hours post-operatively ]
If a patient's VAS score was ≥ 3, morphine will be administered intravenously by a dose of 0.05 mg/kg at 15 minute intervals until complete pain relief will be achieved. Morphine administration will be ceased when the VAS score at rest and coughing was < 3 on assessment or when over-sedation or respiratory depression will occur (a respiratory rate of < 10 bpm). Rescue antiemetic will be given in the form of ondasteron 4 mg IV when patients complained of nausea or vomiting.
Time Frame: 24 hours post-operatively ]

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Rania M. Abdel -Emam、South Egypt cancer Institute, Assuit university hospitals
  • スタディディレクター:Shreen M. Muhammed, A.professor、South Egypt cancer Institute, Assuit university hospitals
  • スタディチェア:Eman A. Ismail、Assiut University Hospitals

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2022年6月1日

一次修了 (予想される)

2024年10月1日

研究の完了 (予想される)

2024年10月1日

試験登録日

最初に提出

2021年9月2日

QC基準を満たした最初の提出物

2021年10月11日

最初の投稿 (実際)

2021年10月25日

学習記録の更新

投稿された最後の更新 (実際)

2021年10月25日

QC基準を満たした最後の更新が送信されました

2021年10月11日

最終確認日

2021年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Q123

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

痛み、術後の臨床試験

Group I (BN10)の臨床試験

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