Post-Operative Spinal Block Duration and Pain Relief After Hip Replacement Surgery: Comparing Single-Shot Spinal Ropivacaine and Bupivacaine (ROBUTHA)
Post-Operative Analgesia and Spinal Block Duration Following Total Hip Arthroplasties: Comparison of Single-Shot Intrathecal Ropivacaine and Bupivacaine in a Randomized Double-Blinded Controlled Study
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Patients undergoing outpatient total hip arthroplasty (THA) under spinal anesthesia require an anesthetic technique that provides adequate surgical anesthesia while allowing rapid postoperative recovery and same-day discharge. Bupivacaine is currently the most commonly used spinal anesthetic for hip arthroplasty, but its relatively long duration of action may delay recovery of motor and sensory function, prolong post-anesthesia care unit (PACU) stay, and increase the risk of urinary retention. Ropivacaine is a long-acting amide-type local anesthetic with a shorter duration of action and a potentially more favorable safety profile, including lower cardiotoxicity and reduced hemodynamic effects. This study aims to determine whether isobaric ropivacaine is more suitable than isobaric bupivacaine for spinal anesthesia in outpatient THA and to identify the optimal dose of ropivacaine for this surgical setting.
Altogether 176 patients scheduled for elective outpatient unilateral total hip arthroplasty at TYKS ORTO Surgical Hospital will be enrolled in this prospective, randomized, double-blind, controlled phase IV clinical trial. Eligible participants will be between 18 and 80 years of age, with a height of 160-186 cm, ASA physical status I-II, and body mass index below 35 kg/m², in accordance with local outpatient surgery criteria. Written informed consent will be obtained from all participants prior to study inclusion.
Patients will be randomized into two study groups to receive either intrathecal isobaric ropivacaine or intrathecal isobaric bupivacaine for spinal anesthesia. Both participants and investigators will remain blinded to group allocation throughout the study period. Spinal anesthesia will be performed according to standard clinical practice. Patient monitoring and perioperative care will follow institutional protocols routinely used for outpatient joint replacement surgery.
Baseline measurements including heart rate, blood pressure, and oxygen saturation will be recorded before administration of spinal anesthesia. After intrathecal injection, patients will undergo continuous monitoring including blood pressure, pulse, electrocardiography (ECG), oxygen saturation, and assessment of sensory block height. Measurements will initially be recorded every five minutes during the intraoperative period and subsequently at longer intervals after transfer to the ward.
The primary outcome of the study is the time to full recovery of sensory and motor function following spinal anesthesia. Secondary outcome measures include the proportion of patients discharged home as planned on the day of surgery, duration of PACU stay and total hospital stay, postoperative pain intensity measured using the Numerical Rating Scale (NRS; minimum 0, maximum 10, higher scores indicating more severe pain), incidence of urinary retention, time required to achieve adequate surgical anesthesia, adequacy of anesthesia during surgery, incidence of postoperative nausea and vomiting (PONV), postoperative opioid consumption, and patient satisfaction with care and recovery.
Postoperative pain management will follow standard institutional protocols. Pain intensity will be assessed regularly in the PACU and surgical ward using the NRS scale. Additional postoperative opioid analgesics may be administered as clinically indicated. Follow-up telephone interviews will be conducted on postoperative days 2 and 3 to assess recovery at home, pain management, discharge-related challenges, and patient satisfaction.
Bupivacaine and ropivacaine are both widely used amide-type local anesthetics for spinal anesthesia in orthopedic surgery. Their mechanism of action is based on reversible blockade of sodium channels in nerve cells, thereby inhibiting nerve impulse conduction. Ropivacaine has been associated with less cardiotoxicity, reduced central nervous system toxicity, and shorter duration of motor blockade compared with bupivacaine, which may improve suitability for outpatient surgery.
Both study medications are routinely used in clinical practice at TYKS ORTO Surgical Hospital and throughout the Nordic countries. Serious adverse effects are rare and are typically associated with overdose or unintentional intravascular administration. Common effects related to spinal anesthesia include transient hypotension due to sympathetic blockade, urinary retention, post-spinal headache, and temporary back pain. Severe complications such as infection or nerve injury are extremely uncommon. The study specifically aims to evaluate whether shorter-duration spinal anesthesia may reduce delayed recovery and urinary retention while maintaining adequate surgical conditions and postoperative analgesia.
All participant data will be handled confidentially. Personal identifiers will be removed from study documents and replaced with study identification numbers. The code key linking participant identities to study data will be stored separately in a password-protected file accessible only to the research team. Paper records will be maintained in locked facilities at Turku University Hospital, and no identifiable data will be shared outside the study team.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 4
連絡先と場所
研究連絡先
研究連絡先
- 名前:Panu Uusalo, MD, PhD
- 電話番号:+35823133077
- メール:panu.uusalo@varha.fi
研究連絡先のバックアップ
- 名前:Maarit Rantakokko, MD
- メール:maarit.rantakokko@varha.fi
参加基準
適格基準
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:
- 18 - 80 years of age
- Scheduled for a primary elective total hip arthroplasty
- Patient must be a candidate for same day discharge
- Informed consent understood and signed
- Patient is 160 - 186 cm tall
Exclusion Criteria:
- Scheduled bilateral THA
- Contraindication to or failed spinal anesthesia
- Allergy or contraindication to NSAIDs (e.g. chronic kidney disease)
- Diabetes requiring insulin medication
- Preoperative chronic use of illegal substances
- Renal insufficiency (eGFR < 60)
- Unstable psychiatric conditions
- Severe neurological disorder
- Cognitive deficiencies preventing informed consent
- Language barrier preventing completion of study
- Pregnancy or breastfeeding
- Chronic pain syndrome
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
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ:Ropivacaine
Patients receive spinal anesthesia with intrathecal ropivacaine
|
Patients receive spinal anesthesia with intrathecal ropivacaine
|
|
アクティブコンパレータ:Bupivacaine
Patients receive spinal anesthesia with intrathecal bupivacaine
|
Patients receive spinal anesthesia with intrathecal bupivacaine
|
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Return of Sensory and Motor Function
時間枠:24 hours
|
24 hours
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numeric Rating Scale (NRS) for Postoperative Pain
時間枠:24 hours
|
Pain intensity score assessed using the Numeric Rating Scale (NRS) for Pain (range 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain; higher scores indicate worse pain outcomes).
|
24 hours
|
|
Urinary retention
時間枠:24 hours
|
24 hours
|
|
|
Post-operative nausea and vomiting
時間枠:24 hours
|
24 hours
|
|
|
Postoperative opioid consumption in morphine milligram equivalents (MME)
時間枠:24 hours
|
24 hours
|
|
|
5-Point Likert Satisfaction Scale
時間枠:24 hours
|
Patient satisfaction score assessed using the 5-Point Likert Satisfaction Scale (range 1 to 5, where 1 indicates very dissatisfied and 5 indicates very satisfied; higher scores indicate better satisfaction outcomes).
|
24 hours
|
|
Perioperative hemodynamics
時間枠:24 hours
|
Mean, systolic, and diastolic arterial pressure measured by non-invasive oscillometric monitoring and heart rate measured by continuous ECG/pulse oximetry at 10-minute intervals intraoperatively and in the PACU.
Incidence of hypotension (MAP <65 mmHg) is also recorded.
Units of measure: mmHg, beats per minute, and % of patients with hypotensive episodes.
|
24 hours
|
|
Onset time of block
時間枠:24 hours
|
24 hours
|
|
|
Adequacy of anesthesia
時間枠:24 hours
|
Sensory block level assessed by cold sensation testing (dermatomal level) at 10-minute intervals following spinal anesthesia, and incidence of requirement for supplemental sedation or analgesia recorded from anesthesia and PACU charts.
Units of measure: dermatomal level (T-level) and % of patients requiring supplemental medication.
|
24 hours
|
|
Same day discharge rate
時間枠:24 hours
|
24 hours
|
|
|
Length of stay in the postoperative care unit and length of hospital stay
時間枠:72 hours
|
72 hours
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- スタディディレクター:Panu Uusalo, MD, PhD、University of Turku and Turku University Hospital, Finland
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- T2025/18111
- 2025-522358-38-02 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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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