Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty (THA)
Comparison of the Efficacy and Safety of Three Regional Anesthesia Strategies in Patients Undergoing Elective Total Hip Arthroplasty: A Prospective, Randomized, Multicenter Clinical Trial
The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty.
The main questions this study aims to answer are:
Which anesthesia method provides better pain control after surgery? Which method reduces the need for opioid pain medicines? Are there differences in side effects and recovery between the approaches? Participants will be randomly assigned to one of three groups. All participants will receive spinal anesthesia. One group will receive spinal anesthesia with intrathecal morphine. The other two groups will receive spinal anesthesia combined with a nerve block called the pericapsular nerve group (PENG) block, with or without the addition of dexamethasone.
Participants will have their pain levels measured at regular times during the first two days after surgery. Researchers will also record opioid use, time to first pain medication, ability to move after surgery, length of hospital stay, and any side effects such as nausea or itching. Blood tests will be used to measure markers of inflammation.
The results of this study may help doctors choose safer and more effective pain control strategies for people undergoing hip replacement surgery.
調査の概要
状態
詳細な説明
Postoperative pain after total hip arthroplasty is associated with increased opioid use, delayed mobilization, and a higher risk of adverse events, particularly in older adults. Spinal anesthesia with intrathecal morphine is widely used to improve postoperative analgesia; however, it may be associated with opioid-related side effects such as nausea, pruritus, urinary retention, and respiratory depression. Ultrasound-guided regional nerve blocks, including the pericapsular nerve group (PENG) block, have emerged as opioid-sparing alternatives that may provide effective analgesia while preserving motor function.
This prospective, randomized, multicenter clinical trial is designed to compare the efficacy and safety of three regional anesthesia strategies in patients undergoing elective total hip arthroplasty. Participants aged 60 years and older will be randomly assigned in a 1:1:1 ratio to one of three study groups: spinal anesthesia with intrathecal morphine; spinal anesthesia combined with a PENG block; or spinal anesthesia combined with a PENG block using perineural dexamethasone as an adjuvant.
All participants will receive standardized spinal anesthesia with ropivacaine. In the control group, intrathecal morphine will be administered as part of routine spinal anesthesia. In the intervention groups, the PENG block will be performed under ultrasound guidance using ropivacaine, with or without the addition of dexamethasone. Perioperative care, postoperative analgesic protocols, and rehabilitation pathways will be standardized across all study centers to minimize variability.
Pain intensity at rest and during movement will be assessed using a visual analog scale at predefined time points within the first 48 hours after surgery. Secondary outcomes include total opioid consumption, time to first rescue analgesia, early mobilization, length of hospital stay, incidence of opioid-related and block-related adverse events, and changes in inflammatory markers measured in peripheral blood.
The results of this study will provide comparative evidence on opioid-based versus opioid-sparing regional anesthesia strategies for hip arthroplasty and may help inform clinical decision-making aimed at improving postoperative pain control, functional recovery, and safety in older surgical patients.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Malgorzata Reysenr, MD PhD
- 電話番号：608762068
- メール：mreysner@ump.edu.pl
研究連絡先のバックアップ
- 名前：Malgorzata Reysner, MD PhD
- 電話番号：608762068
- メール：mreysner@ump.edu.pl
研究場所
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Poznan、ポーランド、62-701
- Poznan University of Medical Sciences
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参加基準
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
説明
Inclusion Criteria:
- Adults aged 60 to 100 years
- Scheduled for elective total hip arthroplasty
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone
- Coagulation disorders or ongoing anticoagulant therapy contraindicating spinal anesthesia or regional nerve blocks
- Infection at the site of spinal or peripheral nerve block injection
- Pre-existing neurological disorders affecting sensory or motor function
- Severe hepatic or renal insufficiency
- Chronic opioid use for more than 3 months prior to surgery
- Refusal or inability to provide informed consent
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：なし（オープンラベル）
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：Spinal Anesthesia With Intrathecal Morphine
Participants will receive spinal anesthesia with intrathecal ropivacaine combined with intrathecal morphine.
Ropivacaine 0.5% (10-15 mg) will be administered intrathecally, followed by intrathecal morphine at a dose of 100 micrograms as part of standard anesthesia care.
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Intrathecal morphine administered as part of spinal anesthesia for postoperative pain control during elective total hip arthroplasty.
他の名前：
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実験的：Spinal Anesthesia Plus PENG Block
Participants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block.
The PENG block will be performed using 20 mL of ropivacaine 0.2% administered as a single injection.
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Ultrasound-guided pericapsular nerve group block performed as an adjunct to spinal anesthesia to provide postoperative analgesia.
他の名前：
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実験的：Spinal Anesthesia Plus PENG Block With Dexamethasone
Participants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block.
The PENG block will be performed using 20 mL of ropivacaine 0.2% with the addition of dexamethasone 4 mg administered perineurally as a single injection.
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Perineural dexamethasone administered as an adjuvant to the pericapsular nerve group block to prolong postoperative analgesia.
他の名前：
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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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Total Postoperative Opioid Consumption
時間枠：Up to 48 hours after surgery
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Total amount of opioids administered postoperatively, expressed as intravenous morphine equivalents.
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Up to 48 hours after surgery
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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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Pain scores at rest
時間枠：6 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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6 hours after surgery
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Pain scores durring movement
時間枠：6 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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6 hours after surgery
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Pain scores at rest
時間枠：12 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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12 hours after surgery
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Pain scores durring movement
時間枠：12 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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12 hours after surgery
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Pain scores at rest
時間枠：24 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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24 hours after surgery
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Pain scores durring movement
時間枠：24 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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24 hours after surgery
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Pain scores at rest
時間枠：48 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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48 hours after surgery
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Pain scores durring movement
時間枠：48 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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48 hours after surgery
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Time to First Rescue Analgesia
時間枠：Up to 48 hours after surgery.
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Time from the end of surgery to the first request for rescue analgesic medication.
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Up to 48 hours after surgery.
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Early Mobilization
時間枠：Up to 48 hours after surgery
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Time to first mobilization assessed using the Timed Up and Go test.
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Up to 48 hours after surgery
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Incidence of Opioid-Related Adverse Events
時間枠：Up to 48 hours after surgery.
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Occurrence of opioid-related adverse events, including nausea, vomiting, pruritus, and urinary retention.
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Up to 48 hours after surgery.
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Length of Hospital Stay
時間枠：measured at the day of the discharge from the hospital
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Total duration of postoperative hospitalization measured in days.
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measured at the day of the discharge from the hospital
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協力者と研究者
捜査官
- スタディチェア：Malgorzata Reysner, MD PhD、Poznan University of Medical Sciences
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 1/2026 (Powiślańska Akademia Nauk Stosowanych w Kwidzynie)
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
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