Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy
Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol for Postoperative Pain Control in Percutaneous Nephrolithotomy
調査の概要
詳細な説明
The study protocol was approved by the Local Ethical Committee. Written informed consent was obtained from all patients, before starting to surgery.
The patients were given no premedication. The demographic data of patients (age, gender, the presence of other diseases) were recorded, preoperatively. All patients were applied standard monitoring in the operating room. After the induction of anesthesia provided intravenously propofol (2-3mg/kg) and rocuronium bromide (0.5 mgkg-1), all patients were intubated with a suitable endotracheal tube. Anesthesia maintenance was provided with 1-2% sevoflurane and a 60% nitrous oxide-40% oxygen gas mixture. 0.9% NaCl (5-10 mLkg-1) was started as fluid resuscitation. Urinary catheter was inserted before placement, and then all patients were placed in the prone position.
Postoperatively, duration of surgery, systolic and diastolic blood pressures, heart rate, peripheral oxygen saturation (SBP, DBP, HR, and SpO2), visual analog scales (VAS), side effects such as vomiting and nausea, complications such as pneumothorax, tramadol consumption and additional analgesic requirements of patients were recorded at 1, 2, 4, 6, 12 and 24 h in the postoperative period. These parameters were evaluated by an anesthesiologist in the first 24 hours postoperatively. If the VAS score was >4, patients in both groups were administered diclofenac.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Adana、七面鳥、01230
- Cukurova University Faculty of Medicine
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 53 patients scheduled for percutaneous nephrolithotomy (PNL),
- 18-70 years of age,
- weight between 50-100 kg,
- American Society of Anesthesiologists (ASA) classification I-II were included
Exclusion Criteria:
- The exclusion criteria were refusals by patients,
- coagulation abnormalities,
- patients with spinal deformity,
- cutaneous infection at the injection site and
- a known allergy to drugs.
研究計画
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 |
|---|---|
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アクティブコンパレータ：Group Paravertebral Block
With ultrasound guidance at T10 to L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. 5 mL bupivacaine 0.5% was injected in each dermatome level.
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paravertebral block was performed by ultrasound guidance at T11, T12 and L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. The injection site was covered with sterile drapes, after cleaning with 10% povidone-iodine solution. After, patients in both groups were performed patient controlled analgesia (PCA). The PCA was prepared with 400 mg tramadol into 100 mL of saline. The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
Patients in group T were given intravenously a loading dose of tramadol of 1 mgkg-1, 45 minutes before the end of surgery.
After,patients in both groups were performed patient controlled analgesia (PCA).
The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc., St. Paul, MN) was prepared with 400 mg tramadol into 100 mL of saline.
The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
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プラセボコンパレーター：Group tramadol
Patients in group T were given a loading dose of tramadol of 1 mgkg-1
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Patients in group T were given intravenously a loading dose of tramadol of 1 mgkg-1, 45 minutes before the end of surgery.
After,patients in both groups were performed patient controlled analgesia (PCA).
The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc., St. Paul, MN) was prepared with 400 mg tramadol into 100 mL of saline.
The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
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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 |
|---|---|---|
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Visual Analogue Scale
時間枠：up to 24 hours
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Postoperative pain degree was evaluated by Visual Analogue Scale
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up to 24 hours
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二次結果の測定
結果測定 |
時間枠 |
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tramadol consumption
時間枠：up to 24 hours
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up to 24 hours
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Zehra Hatipoğlu, Assist Prof、Çukurova University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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