Liposomal Bupivacaine vs Ropivacaine for Post-hemorrhoidectomy Analgesia
Liposomal Bupivacaine Versus Ropivacaine for Wound Infiltration Analgesia After Milligan-Morgan Open Hemorrhoidectomy: A Randomized Controlled Trial
調査の概要
状態
詳細な説明
Milligan-Morgan open hemorrhoidectomy is associated with substantial postoperative pain due to rich somatic innervation of the perianal region, wound exposure, anal sphincter spasm, and stimulation during defecation. Optimizing postoperative analgesia is critical for enhanced recovery. Local wound infiltration with ropivacaine is commonly used but provides limited duration of analgesia. Liposomal bupivacaine, formulated with a multivesicular liposomal delivery system, enables sustained release of bupivacaine at the injection site and may prolong local analgesia. However, high-quality comparative evidence between liposomal bupivacaine and ropivacaine for wound infiltration after open hemorrhoidectomy remains limited.
This single-center, prospective, randomized, double-blind controlled trial enrolled patients aged 18-60 years with grade III-IV internal hemorrhoids or mixed hemorrhoids scheduled for elective Milligan-Morgan open hemorrhoidectomy at Tongliao People's Hospital between November 2025 and May 2026. Patients were randomized 1:1 to receive perianal wound infiltration with either 266 mg of liposomal bupivacaine or 200 mg of ropivacaine hydrochloride, both diluted to 30 mL with normal saline and divided into six 5-mL aliquots infiltrated at six predefined perianal clock-face positions. All patients received spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine. Rescue analgesia with oral diclofenac sodium 50 mg was provided when VAS pain score was ≥4.
The primary outcome is resting VAS pain score at 24 hours postoperatively. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative diclofenac sodium consumption during postoperative days 1-3, QoR-40 total scores on postoperative days 1-3, and adverse events (nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, surgical-site infection) within 72 hours.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Xiaona Liu
- 電話番号：+8615894886794
- メール：15894886794@163.com
研究連絡先のバックアップ
- 名前：Yucheng Tian
- 電話番号：+8615942988130
- メール：3216134807@qq.com
研究場所
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Tongliao
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Neimeng、Tongliao、中国、028000
- Tongliao People's Hospital
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コンタクト：
- Bo Sun
- 電話番号：0475-82511603
- メール：tlsyybgs@163.com
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 1. Aged 18-60 years, irrespective of sex 2. Diagnosed with grade III-IV internal hemorrhoids or mixed hemorrhoids based on specialist examination and scheduled to undergo elective Milligan-Morgan open hemorrhoidectomy 3. American Society of Anesthesiologists (ASA) physical status I-III 4. Body mass index (BMI) of 18.0-30.0 kg/m² 5. Able to understand and complete the pain and quality-of-recovery assessments and willing to participate in the study
Exclusion Criteria:
1. Concomitant chronic low back or leg pain, anal fissure, perianal abscess, or other persistent painful conditions 2. Pregnancy, breastfeeding, or plans to become pregnant in the near future 3. Known allergy to bupivacaine, ropivacaine, or any other medication used during the study 4. Long-term regular use of opioids or use of analgesic medications within 48 hours before surgery 5. Obstructive sleep apnea syndrome or severe cardiovascular, cerebrovascular, or pulmonary disease considered to significantly increase risks associated with neuraxial anesthesia or postoperative analgesia 6. Psychiatric or cognitive impairment that precludes completion of study assessments 7. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation
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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：順次割り当て
- 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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実験的：Liposomal Bupivacaine Group
Patients receive perianal wound infiltration with 266 mg of multivesicular liposomal bupivacaine (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL.
The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery.
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266 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
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アクティブコンパレータ：Ropivacaine Group
Patients receive perianal wound infiltration with 200 mg of ropivacaine hydrochloride (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL.
The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery.
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200 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
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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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Resting visual analog scale (VAS) pain score
時間枠：48 hours after surgery
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Pain intensity at rest assessed using a 10-cm VAS, with 0 indicating no pain and 10 indicating the worst imaginable pain.
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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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Resting and movement-evoked VAS pain scores
時間枠：4, 6, 12, 24, and 48 hours after surgery
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Pain intensity at rest and during movement assessed using a 10-cm VAS at predefined postoperative time points.
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4, 6, 12, 24, and 48 hours after surgery
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Cumulative rescue analgesic consumption
時間枠：Postoperative days 1-3 (within 72 hours)
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Cumulative dose of oral diclofenac sodium (mg) consumed as rescue analgesia when VAS pain score ≥4.
Maximum daily dose 150 mg, minimum interval 8 hours
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Postoperative days 1-3 (within 72 hours)
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Quality of Recovery-40 (QoR-40) total score
時間枠：Postoperative days 1, 2, and 3
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The QoR-40 comprises 40 items across five dimensions (physical comfort, emotional state, physical independence, psychological support, and pain).
Total scores range from 40 to 200, with higher scores indicating better postoperative recovery.
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Postoperative days 1, 2, and 3
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Incidence of adverse events
時間枠：Within 72 hours after surgery
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Adverse events including nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, and surgical-site infection
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Within 72 hours after surgery
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協力者と研究者
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 (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
その他の研究ID番号
- TongliaoCPH
- 337087 (レジストリ識別子：China Clinical Trial Registration Center)
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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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