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The Analgesic Efficacy of Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Ultrasound Guided Peripheral Nerve Blocks as a Solo Anesthetic Technique in High Risk Patients Undergoing Unilateral Above Knee Amputation .

2026年7月10日 更新者:paula atef gobran kamil、Kasr El Aini Hospital

The Analgesic Efficacy of Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Ultrasound Guided Peripheral Nerve Blocks as a Solo Anesthetic Technique in High Risk Patients Undergoing Unilateral Above Knee Amputation : A Randomized Double Blinded Study

The aim of this study is to compare the analgesic efficacy and safety of dexmedetomidine versus fentanyl as adjuvants to bupivacaine in ultrasound-guided combined supra-inguinal fascia iliaca and proximal sciatic nerve blocks used as a solo anesthetic technique in high-risk patients undergoing unilateral above knee amputation.

調査の概要

詳細な説明

Above knee amputation (AKA) is a major surgical procedure often performed for non salvageable lower limb such as severe trauma , peripheral arterial diseases or infection . however it carries significant risks and complications . The overall mortality and morbidity rates are also substantial, with one-year mortality rates reported as high as 40-50% in some populations.

Anesthesia in above-knee amputation procedures poses its own set of risks, especially in patients with advanced age or multiple comorbidities. General anesthesia (GA) may be associated with postoperative pulmonary complications, prolonged recovery, and hemodynamic instability. On the other hand, spinal anesthesia offers benefits such as reduced thromboembolic events and faster postoperative recovery, but carries risks including hypotension, spinal hematoma, and post-dural puncture headache .

Peripheral nerve blocks (PNBs) as a solo anesthetic technique offer significant hemodynamic advantages compared to neuroaxial and general anesthesia , this makes them especially beneficial for patients with cardiovascular compromise or bad chest conditions.

Effective pain management is crucial to improve patient outcomes, promoting early mobilization, and reducing the risks of complications such as deep vein thrombosis or chronic pain syndromes .

Patients with multiple risk factors such as cardiovascular disease, respiratory problems have a higher risk of complications when general or spinal anesthesia is used. In such cases ultrasound guided regional anesthesia becomes an excellent alternative .. So The combination of supra-inguinal fascia iliaca block and sciatic nerve block has emerged as a promising regional anesthetic approach for above-knee amputation, particularly in patients who are poor candidates for general or neuraxial anesthesia. This technique provides comprehensive coverage of the femoral, lateral femoral cutaneous, obturator, and sciatic nerves, allowing for adequate surgical anesthesia without the need for airway manipulation. It offers advantages such as hemodynamic stability, reduced opioid consumption, and fewer respiratory complications, making it especially beneficial in elderly and high-risk patients. When performed under ultrasound guidance, this approach enhances block accuracy and safety, positioning it as a viable solo anesthetic technique for AKA. The technique allows for adequate surgical anesthesia with preserved hemodynamic stability and minimal systemic drug exposure. Clinical reports have demonstrated its success in providing effective anesthesia with high patient and surgeon satisfaction, especially when performed under ultrasound guidance.

Dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties which could improve the quality of the block while reducing opioid consumption and their associated side effects. It reduces pain after knee arthroscopy mainly by peripheral and central mechanisms through stimulation of presynaptic α2- adrenoceptors .

On the other hand, fentanyl, an opioid, is commonly used to provide potent analgesia in regional blocks but carries risks of respiratory depression and other opioid-related complications . There over, this study aims to compare dexmedetomidine versus fentanyl as adjuvant to bupivacaine in ultrasound-guided supra inguinal fascia iliaca and sciatic nerve block for anesthetic management for unilateral above knee amputation in high risk patients as a solo anesthetic technique ..

While several studies have evaluated the efficacy of peripheral nerve blocks in lower limb surgeries, few have investigated their use as a sole anesthetic technique specifically in high-risk patients undergoing above-knee amputation (AKA). Moreover, the comparative role of different adjuvants such as dexmedetomidine versus fentanyl in this setting remains underexplored. There is a clear need for well-designed randomized trials to guide anesthetic decision-making in this fragile patient population.

研究の種類

介入

入学 (推定)

64

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • - Age ≥18 years
  • Both sexes
  • ASA III-IV
  • Documented cardiac disease (e.g., EF < 40%, NYHA II or higher)
  • Documented pulmonary disease (e.g., COPD with FEV1 < 60%)
  • Scheduled for above-knee amputations

Exclusion Criteria:

  • Neurological or intellectual disability
  • Drug abuse
  • Allergy to study drugs
  • Pregnancy
  • Contraindications to regional anesthesia (e.g., coagulopathy, local infection)
  • Significant renal or hepatic impairment( plts <75000 or INR >1.5)
  • Current anticoagulant therapy
  • severe haemodynamically unstability at the time of block performance, defined as map > 65 mmhg but achieved by high-dose vasopressors (e.g., norepinephrine ≥ 0.1 mcg/kg/min) after fluid ressuscitation .

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:非ランダム化
  • 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:dexmedetomidine group
patients receiving peripheral nerve blocks for above-knee amputation with dexmedetomidine added to the local anesthetic solution
Dexmedetomidine added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.
アクティブコンパレータ:fentanyl group
patients receiving peripheral nerve blocks for above-knee amputation with fentanyl added to the local anesthetic solution
Fentanyl added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.

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 to the first request for the rescue analgesia
時間枠:24 hours postoperative
the first time the patient needs analgesia postoperative
24 hours postoperative

二次結果の測定

結果測定
メジャーの説明
時間枠
Total morphine consumption postoperative.
時間枠:24 hours postoperative
the total dose of morphine given to the patient in the 24 hours postoperative
24 hours postoperative
Intraoperative Pain score (VAS).
時間枠:from block performance till 24 hours postopertaive
assessment of pain intensity using the visual analogue score (VAS) ranging from 0 to 10 where 0 indicates no pain and 10 indicate the worst pain imaginable , higher scores indicate worse pain
from block performance till 24 hours postopertaive
Patient satisfaction
時間枠:24 hours postoperative
by a scale from 1 to 5 where is 1 is very dissatisfied and 5 is very satisfied higher scores indicate greater patient satisfaction
24 hours postoperative
intraoperative heart rate
時間枠:intraoperative
measurments of intraoperative HR every 5 mins
intraoperative
Complications ( nausea - vomiting - bradycardia - hypotension .... )
時間枠:24 hours post operative
Any complication that happened intra or post operative
24 hours post operative
intraoperative mean arterial blood pressure
時間枠:intraoperative
measurment of MAP every 5 mins
intraoperative

協力者と研究者

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スポンサー

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 (推定)

2026年7月1日

一次修了 (推定)

2027年1月1日

研究の完了 (推定)

2027年3月1日

試験登録日

最初に提出

2026年5月28日

QC基準を満たした最初の提出物

2026年6月6日

最初の投稿 (実際)

2026年6月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月13日

QC基準を満たした最後の更新が送信されました

2026年7月10日

最終確認日

2026年5月1日

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