Fentanyl Versus Tramadol as Co-administrator to Bupivacaine
Fentanyl Versus Tramadol as Co-administrator to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade: Pons and Cons
調査の概要
詳細な説明
There are multiple controversies among the previous studies for the use of different opioids as adjuvants for brachial plexus blockade to improve various block characteristics. Moreover, limited studies estimate the pons and cons of tramadol versus fentanyl as co-administrator to bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade.
In our study, we aim to assess the utility of fentanyl versus tramadol as co-administrator to bupivacaine in ultrasound-guided supraclavicular brachial plexus blockade in upper limb surgeries in a prospective randomized controlled fashion. The primary outcome is to compare between the efficacy of tramadol versus fentanyl as adjuvants on the onset and duration of sensory and motor block and the secondary outcome is to compare between the efficacy of tramadol versus fentanyl as adjuvants on postoperative analgesia, time of the request to rescue analgesia, postoperative analgesic consumption, and complications.
The patients were aged between 18 and 60, both gender, and the American Society of Anesthesiologists (ASA) physical status I/II. However, patients who had bleeding disorders got opioid analgesics or monoamine oxidase inhibitors before surgery, had a history of seizures, respiratory or cardiac diseases, local infections at the site where needle for the block is to be inserted, pregnant woman and in whom the block effect was partial and required supplementary anesthesia were excluded from the study.
Patients were randomly allocated into three groups for ultrasound-guided supraclavicular brachial plexus block. Randomization was established using the computer-generated closed envelopes method.
Group B (bupivacaine group): patients received 20 ml bupivacaine 0.5% plus 2 ml normal saline Group F (fentanyl group): patients received 20 ml bupivacaine 0.5% plus fentanyl (1µg/kg-2 ml) Group T (tramadol group): patients received 20 ml bupivacaine 0.5% plus tramadol (1mg/kg-2 ml)
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Aswan、エジプト、81511
- Aswan University Hospital
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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:
- American Society of Anesthesiologists (ASA) physical status I/II. scheduled for forearm or hand surgery
Exclusion Criteria:
- bleeding disorders
- patients who got opioid analgesics or monoamine oxidase inhibitors before surgery,
- history of seizures, respiratory or cardiac diseases
- local infections at the site where the needle for the block is to be inserted
- a pregnant woman
- the block effect was partial and required supplementary anesthesia
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：トリプル
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 B (bupivacaine group)
patients received 20 ml bupivacaine 0.5% plus normal saline (2ml)
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Ultrasound-guided supraclavicular brachial plexus block was done using an ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe.
The brachial plexus and its relation to the surrounding structures were viewed while the patient was supine and the head turned 45° to the contralateral side.
In the supraclavicular fossa, the probe was placed in the coronal plane to visualize the subclavian artery and the brachial plexus in a transverse sectional view.
After skin sterilization and local anesthetic administration, an insulated needle was then introduced lateral to the ultrasound probe and parallel to the long axis of the probe.
Once the needle penetrated the brachial plexus cluster, the local anesthetic mixture was injected incrementally after negative aspiration for blood or air just next to the artery, then the needle was repositioned to inject on the upper pole of the artery.
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アクティブコンパレータ：Group F (fentanyl group)
patients received 20 ml bupivacaine 0.5% plus fentanyl (100µg-2 ml)
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Ultrasound-guided supraclavicular brachial plexus block was done using an ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe.
The brachial plexus and its relation to the surrounding structures were viewed while the patient was supine and the head turned 45° to the contralateral side.
In the supraclavicular fossa, the probe was placed in the coronal plane to visualize the subclavian artery and the brachial plexus in a transverse sectional view.
After skin sterilization and local anesthetic administration, an insulated needle was then introduced lateral to the ultrasound probe and parallel to the long axis of the probe.
Once the needle penetrated the brachial plexus cluster, the local anesthetic mixture was injected incrementally after negative aspiration for blood or air just next to the artery, then the needle was repositioned to inject on the upper pole of the artery.
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アクティブコンパレータ：Group T (tramadol group)
patients received 20 ml bupivacaine 0.5% plus tramadol (100mg-2 ml)
|
Ultrasound-guided supraclavicular brachial plexus block was done using an ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe.
The brachial plexus and its relation to the surrounding structures were viewed while the patient was supine and the head turned 45° to the contralateral side.
In the supraclavicular fossa, the probe was placed in the coronal plane to visualize the subclavian artery and the brachial plexus in a transverse sectional view.
After skin sterilization and local anesthetic administration, an insulated needle was then introduced lateral to the ultrasound probe and parallel to the long axis of the probe.
Once the needle penetrated the brachial plexus cluster, the local anesthetic mixture was injected incrementally after negative aspiration for blood or air just next to the artery, then the needle was repositioned to inject on the upper pole of the artery.
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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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感覚ブロックの持続時間 (時間)
時間枠：24時間
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感覚ブロックの発症から手術部位の感覚が回復するまでの時間
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24時間
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モーターブロックの持続時間 (時間)
時間枠：24時間
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運動ブロックの開始から、手と手首の全体的な可動性が回復するまでの時間です。
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24時間
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Onset time of sensory block in minutes
時間枠：40 minutes
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After the injection of the solution, every patient was checked for the onset of sensory blockade using goose soaked with iced normal saline by the following scale (three-point scale): Grade 0= perceived as normal sensation, Grade 1 = loss of cold sensation (analgesia), Grade 2= loss of sensation of touch (anesthesia).
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40 minutes
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onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)
時間枠：40 minutes
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the modified Bromage scale (Three-point scale): Grade 0: Normal motor function, Grade 1: Decreased motor strength with the ability to move the fingers only, Grade 2: Complete motor block with an inability to move the fingers.
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40 minutes
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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術後の最初の鎮痛要求時間 (時間単位)
時間枠：24時間
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完全な感覚ブロックの時点から、VAS > 4 cm の場合に鎮痛を救出するよう要求するまでの時間。
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24時間
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MmHg の平均血圧
時間枠：24時間
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ブロック前 (0 分) と、ブロック後 5、10、15、30 分、1、2、3、6、12、18、24 時間後に測定
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24時間
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心拍数/分
時間枠：24時間
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ブロック前 (0 分) と、ブロック後 5、10、15、30 分、1、2、3、6、12、18、24 時間後に測定しました。
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24時間
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末梢酸素飽和度
時間枠：24時間
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ブロック前 (0 分) と、ブロック後 5、10、15、30 分、1、2、3、6、12、18、24 時間後に測定しました。
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24時間
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Visual analog scale (VAS): the VAS consisted of a straight, vertical 10-cm line; the bottom point represented "no pain" = (0 cm) and the top "the worst pain you ever have" = (10 cm).
時間枠：24 hours
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Patients were asked to rate their pain intensity at 1, 2, 4, 6, 12, 18, and 24 h after the block
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24 hours
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Rescue analgesia in the form of 0.05 mg/kg morphine sulfate intravenously
時間枠：24 hours
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was given when VAS ≥ 4 cm
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24 hours
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協力者と研究者
捜査官
- 主任研究者：huda fahmy, ph D、Aswan University
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 (実際)
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
本研究に関する用語
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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