Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Effect of Epidural Hydroxyethyl Starch Administration for Prevention of Post-Dural Puncture Headache in Parturients: A Multi-center Prospective Cohort Study
The incidence of accidental dural puncture (ADP) among parturients receiving neuraxial labor analgesia has been reported to range from 1% to 1.5%. Post-dural puncture headache (PDPH) is a headache caused by low cerebrospinal fluid pressure resulting from substantial cerebrospinal fluid leakage after dural and arachnoid puncture. Epidural filling with hydroxyethyl starch (HES) via an epidural catheter has been used to prevent PDPH in patients with ADP. This multicenter prospective cohort study aimed to evaluate the effect of epidural HES filling in preventing PDPH in parturients who experienced ADP during epidural labor analgesia or neuraxial anesthesia for cesarean delivery.
調査の概要
状態
詳細な説明
Accidental dural puncture (ADP) is a common complication of epidural puncture. Studies have reported that the incidence of ADP among parturients receiving neuraxial labor analgesia ranges from 1% to 1.5%. Post-dural puncture headache (PDPH) is a headache caused by low cerebrospinal fluid (CSF) pressure resulting from substantial CSF leakage after dural and arachnoid puncture. It typically occurs when the dura is accidentally punctured by a relatively large 16- or 18-gauge epidural needle during epidural labor analgesia or anesthesia, and occasionally after spinal anesthesia or combined spinal-epidural anesthesia performed with a 25-gauge fine needle. The literature reports that the incidence of PDPH among parturients undergoing neuraxial puncture is 0.4% to 1.5%, and that the incidence of PDPH after ADP is 50% to 80%, which is far higher than that in non-obstetric patients.
Current guideline-recommended treatments for PDPH include: (1) nonpharmacological conservative treatment, including oral fluids or intravenous hydration to maintain or increase CSF production, bed rest, and use of an abdominal binder. Although commonly used, their efficacy remains uncertain. (2) Pharmacological treatment: multimodal analgesia with acetaminophen and nonsteroidal anti-inflammatory drugs is recommended, and short-term opioid use may also be considered. Although these can relieve some symptoms, the potential transfer of drugs into breast milk and effects on the neonate should be considered at high doses. (3) Epidural blood patch (EBP) is the recommended standard treatment. It involves slow, fractionated injection of 15-20 mL of autologous blood into the epidural space, which increases epidural pressure, redistributes CSF, and forms a local blood clot that seals the dural tear, thereby reducing CSF leakage and gradually relieving the headache. However, not all patients with ADP develop PDPH; a strategy of routine prophylactic EBP would expose some patients to unnecessary potential risks.
Epidural filling with crystalloids or colloids is another alternative treatment option, which involves injecting normal saline, dextran, or hydroxyethyl starch (HES) through an epidural catheter to increase CSF pressure. Bel et al. reported a case in which epidural dextran filling successfully treated spontaneous intracranial hypotension in a pregnant woman. Aldrete et al. reported 13 patients with PDPH refractory to EBP whose headaches completely resolved after epidural dextran filling. Reynvoet et al. reported a patient with PDPH accompanied by hearing loss in whom two EBPs failed to relieve symptoms; at 8 weeks, epidural dextran filling was performed, and the symptoms completely resolved. Case reports from China and other countries have also described the preventive and therapeutic effects of epidural HES filling for the prevention and treatment of PDPH, with no adverse events reported during long-term follow-up.
This multicenter prospective cohort study aimed to evaluate the effect of epidural HES filling in preventing PDPH in parturients who experienced ADP during epidural labor analgesia or neuraxial anesthesia for cesarean delivery.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Zhi-Yu Geng, MD
- 電話番号：86 10 83572460
- メール：gengzhiyu2013@163.com
研究連絡先のバックアップ
- 名前：Dong-Xin Wang, MD, PhD
- 電話番号：86 10 83572784
- メール：wangdongxin@hotmail.com
研究場所
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-
Beijing Municipality
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Beijing、Beijing Municipality、中国、100034
- Peking University First Hospital
-
コンタクト：
- Zhi-Yu Geng, MD
- 電話番号：010-83572460
- メール：gengzhiyu2013@163.com
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Beijing、Beijing Municipality、中国、100080
- Beijing Haidian Maternal and Child Health Hospital
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コンタクト：
- Bo Lei, MD
- メール：Leibo1977@163.com
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Ningxia
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Yinchuan、Ningxia、中国、750001
- Ningxia Maternal and Child Health Hospital
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コンタクト：
- Hong-Ping Li, MD
- メール：1395078537@163.com4
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Shanxi
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Taiyuan、Shanxi、中国、030009
- Taiyuan central hospital
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コンタクト：
- Jian-Ying Ding, MD
- メール：dingjianying-2004@163.com
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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
サンプリング方法
調査対象母集団
The study population comprised parturients aged ≥18 years who experienced accidental dural puncture (ADP) during epidural labor analgesia or neuraxial anesthesia for cesarean delivery at the participating centers during the enrollment period.
説明
Inclusion Criteria:
- Age ≥18 years.
- Have experienced accidental dural puncture (ADP) during epidural labor analgesia or neuraxial anesthesia for cesarean delivery.
Exclusion Criteria:
- Age <18 years.
- ASA physical status ≥IV.
- Cesarean delivery under general anesthesia.
- Preoperative inability to communicate due to intellectual or language impairment.
- Pre-existing cerebrovascular disease, migraine, or chronic headache.
- Long-term use of oral analgesics.
- Preoperative coagulation dysfunction.
- Platelet count <80×10⁹/L.
- Refusal to participate.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Epidural hydroxyethyl starch group
For parturients with accidental dural puncture during labor epidural analgesia, after successful reinsertion of the epidural catheter at a different interspace, 15 mL of hydroxyethyl starch (HES) will be administered into the epidural space at two time points: the first at 30 minutes after the initial epidural dose administered through the reinserted catheter, and the second before catheter removal 24 hours after delivery. For parturients with accidental dural puncture during cesarean delivery, 15 mL of HES will be administered into the epidural space at two time points: after delivery of the fetus and before catheter removal at the end of the 48-hour analgesia period. |
For parturients with accidental dural puncture during labor epidural analgesia, after successful reinsertion of the epidural catheter at a different interspace, 15 mL of hydroxyethyl starch (HES) will be administered into the epidural space at two time points: the first at 30 minutes after the initial epidural dose administered through the reinserted catheter, and the second before catheter removal 24 hours after delivery. For parturients with accidental dural puncture during cesarean delivery, 15 mL of HES will be administered into the epidural space at two time points: after delivery of the fetus and before catheter removal at the end of the 48-hour analgesia period.
他の名前：
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Non epidural hydroxyethyl starch group
For parturients with accidental dural puncture during labor epidural analgesia, after successful reinsertion of the epidural catheter at a different interspace, no HES will be administered into the epidural space in the control group. The corresponding time points in the intervention group are 30 minutes after the initial epidural dose administered through the reinserted catheter and before catheter removal 24 hours after delivery. For parturients with accidental dural puncture during cesarean delivery, no HES will be administered into the epidural space in the control group. The corresponding time points in the intervention group are after delivery of the fetus and before catheter removal at the end of the 48-hour analgesia period. |
For parturients with accidental dural puncture during labor epidural analgesia, after successful reinsertion of the epidural catheter at a different interspace, no HES will be administered into the epidural space in the control group. The corresponding time points in the intervention group are 30 minutes after the initial epidural dose administered through the reinserted catheter and before catheter removal 24 hours after delivery. For parturients with accidental dural puncture during cesarean delivery, no HES will be administered into the epidural space in the control group. The corresponding time points in the intervention group are after delivery of the fetus and before catheter removal at the end of the 48-hour analgesia period.
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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Incidence of post-dural puncture headache (PDPH) within 7 days.
時間枠：Up to 7 days after accidental dural puncture.
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According to the International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria for post-dural puncture headache (PDPH), PDPH is defined as: a history of dural puncture; headache occurring within 5 days after dural puncture; headache consistent with low cerebrospinal fluid pressure headache; and not better accounted for by another ICHD-3 diagnosis. |
Up to 7 days after accidental dural puncture.
|
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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Duration of post-dural puncture headache (PDPH)
時間枠：Up to 2 weeks after accidental dural puncture.
|
Duration of PDPH is defined as the time from the onset of PDPH to complete resolution of headache, recorded in days. Patients without resolution by the end of follow-up will be censored at the last follow-up visit. |
Up to 2 weeks after accidental dural puncture.
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Severity of post-dural puncture headache (PDPH)
時間枠：Up to 2 weeks after accidental dural puncture.
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PDPH severity was graded on a 0-10 numeric rating scale (NRS) as mild (1-3), moderate (4-6), or severe (7-10). |
Up to 2 weeks after accidental dural puncture.
|
協力者と研究者
協力者
捜査官
- 主任研究者：Dong-Xin Wang, MD, PhD、Peking University First Hospital
出版物と役立つリンク
一般刊行物
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- Sun S, Huang SQ. Epidural injection of hydroxyethyl starch in the management of post-dural puncture headache: a case series. Int J Clin Exp Med. 2015 May 15;8(5):8254-8. eCollection 2015.
- Vassal O, Baud MC, Bolandard F, Bonnin M, Vielle E, Bazin JE, Chassard D. Epidural injection of hydroxyethyl starch in the management of postdural puncture headache. Int J Obstet Anesth. 2013 Apr;22(2):153-5. doi: 10.1016/j.ijoa.2013.01.003. Epub 2013 Mar 7.
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その他の研究ID番号
- 2026R0413-0002
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