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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Zhi-Yu Geng, MD
- 电话号码：86 10 83572460
- 邮箱：gengzhiyu2013@163.com
研究联系人备份
- 姓名：Dong-Xin Wang, MD, PhD
- 电话号码：86 10 83572784
- 邮箱：wangdongxin@hotmail.com
学习地点
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100034
- Peking University First Hospital
-
接触：
- Zhi-Yu Geng, MD
- 电话号码：010-83572460
- 邮箱：gengzhiyu2013@163.com
-
Beijing、Beijing Municipality、中国、100080
- Beijing Haidian Maternal and Child Health Hospital
-
接触：
- Bo Lei, MD
- 邮箱：Leibo1977@163.com
-
-
Ningxia
-
Yinchuan、Ningxia、中国、750001
- Ningxia Maternal and Child Health Hospital
-
接触：
- Hong-Ping Li, MD
- 邮箱：1395078537@163.com4
-
-
Shanxi
-
Taiyuan、Shanxi、中国、030009
- Taiyuan central hospital
-
接触：
- Jian-Ying Ding, MD
- 邮箱：dingjianying-2004@163.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
其他名称：
|
|
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.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of post-dural puncture headache (PDPH) within 7 days.
大体时间：Up to 7 days after accidental dural puncture.
|
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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of post-dural puncture headache (PDPH)
大体时间：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.
|
|
Severity of post-dural puncture headache (PDPH)
大体时间：Up to 2 weeks after accidental dural puncture.
|
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.
|
合作者和调查者
合作者
调查人员
- 首席研究员：Dong-Xin Wang, MD, PhD、Peking University First Hospital
出版物和有用的链接
一般刊物
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Van de Velde M, Schepers R, Berends N, Vandermeersch E, De Buck F. Ten years of experience with accidental dural puncture and post-dural puncture headache in a tertiary obstetric anaesthesia department. Int J Obstet Anesth. 2008 Oct;17(4):329-35. doi: 10.1016/j.ijoa.2007.04.009. Epub 2008 Aug 8.
- Arevalo-Rodriguez I, Ciapponi A, Roque i Figuls M, Munoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009199. doi: 10.1002/14651858.CD009199.pub3.
- Uppal V, Russell R, Sondekoppam RV, Ansari J, Baber Z, Chen Y, DelPizzo K, Dirzu DS, Kalagara H, Kissoon NR, Kranz PG, Leffert L, Lim G, Lobo C, Lucas DN, Moka E, Rodriguez SE, Sehmbi H, Vallejo MC, Volk T, Narouze S. Evidence-based clinical practice guidelines on postdural puncture headache: a consensus report from a multisociety international working group. Reg Anesth Pain Med. 2024 Jul 8;49(7):471-501. doi: 10.1136/rapm-2023-104817.
- Berger CW, Crosby ET, Grodecki W. North American survey of the management of dural puncture occurring during labour epidural analgesia. Can J Anaesth. 1998 Feb;45(2):110-4. doi: 10.1007/BF03013247.
- Cohen S, Greenberger C, Aptekman B, Rabkin V, Weiniger CF. Incidence and management of accidental dural puncture and postdural puncture headache in parturients: Retrospective database study. Eur J Anaesthesiol. 2025 Jun 1;42(6):492-499. doi: 10.1097/EJA.0000000000002130. Epub 2025 Feb 12.
- Paech M, Banks S, Gurrin L. An audit of accidental dural puncture during epidural insertion of a Tuohy needle in obstetric patients. Int J Obstet Anesth. 2001 Jul;10(3):162-7. doi: 10.1054/ijoa.2000.0825.
- Guglielminotti J, Landau R, Li G. Major Neurologic Complications Associated With Postdural Puncture Headache in Obstetrics: A Retrospective Cohort Study. Anesth Analg. 2019 Nov;129(5):1328-1336. doi: 10.1213/ANE.0000000000004336.
- Makito K, Matsui H, Fushimi K, Yasunaga H. Incidences and risk factors for post--dural puncture headache after neuraxial anaesthesia: A national inpatient database study in Japan. Anaesth Intensive Care. 2020 Sep;48(5):381-388. doi: 10.1177/0310057X20949555. Epub 2020 Oct 6.
- Gaiser RR. Postdural Puncture Headache: An Evidence-Based Approach. Anesthesiol Clin. 2017 Mar;35(1):157-167. doi: 10.1016/j.anclin.2016.09.013.
- Uppal V, Russell R, Sondekoppam R, Ansari J, Baber Z, Chen Y, DelPizzo K, Dirzu DS, Kalagara H, Kissoon NR, Kranz PG, Leffert L, Lim G, Lobo CA, Lucas DN, Moka E, Rodriguez SE, Sehmbi H, Vallejo MC, Volk T, Narouze S. Consensus Practice Guidelines on Postdural Puncture Headache From a Multisociety, International Working Group: A Summary Report. JAMA Netw Open. 2023 Aug 1;6(8):e2325387. doi: 10.1001/jamanetworkopen.2023.25387.
- Binyamin Y, Heesen P, Orbach-Zinger S, Gozal Y, Halimi D, Frenkel A, Ioscovich A. Chronic pain in parturients with an accidental dural puncture: A case-controlled prospective observational study. Acta Anaesthesiol Scand. 2021 Aug;65(7):959-966. doi: 10.1111/aas.13816. Epub 2021 Mar 24.
- Iwase Y, Suzuki M, Bito H. A case report of intracranial hemorrhage after spinal anesthesia. JA Clin Rep. 2017;3(1):11. doi: 10.1186/s40981-017-0081-x. Epub 2017 Mar 9.
- Orbach-Zinger S, Eidelman LA, Livne MY, Matkovski O, Mangoubi E, Borovich A, Wazwaz SA, Ioscovich A, Zekry ZHB, Ariche K, Weiniger CF. Long-term psychological and physical outcomes of women after postdural puncture headache: A retrospective, cohort study. Eur J Anaesthesiol. 2021 Feb 1;38(2):130-137. doi: 10.1097/EJA.0000000000001297.
- Moore AR, Wieczorek PM, Carvalho JCA. Association Between Post-Dural Puncture Headache After Neuraxial Anesthesia in Childbirth and Intracranial Subdural Hematoma. JAMA Neurol. 2020 Jan 1;77(1):65-72. doi: 10.1001/jamaneurol.2019.2995.
- Booth JL, Pan PH, Thomas JA, Harris LC, D'Angelo R. A retrospective review of an epidural blood patch database: the incidence of epidural blood patch associated with obstetric neuraxial anesthetic techniques and the effect of blood volume on efficacy. Int J Obstet Anesth. 2017 Feb;29:10-17. doi: 10.1016/j.ijoa.2016.05.007. Epub 2016 Jun 3.
- Bel I, Moreno LA, Gomar C. Epidural dextran-40 and paramethasone injection for treatment of spontaneous intracranial hypotension. Can J Anaesth. 2006 Jun;53(6):591-4. doi: 10.1007/BF03021850.
- Aldrete JA. Persistent post-dural-puncture headache treated with epidural infusion of dextran. Headache. 1994 May;34(5):265-7. doi: 10.1111/j.1526-4610.1994.hed3405265.x.
- Reynvoet ME, Cosaert PA, Desmet MF, Plasschaert SM. Epidural dextran 40 patch for postdural puncture headache. Anaesthesia. 1997 Sep;52(9):886-8. doi: 10.1111/j.1365-2044.1997.183-az0320.x.
- Vassal O, Del Carmine P, Beuriat PA, Desgranges FP, Gadot N, Allaouchiche B, Timour-Chah Q, Stewart A, Chassard D. Neurotoxicity of intrathecal 6% hydroxyethyl starch 130/0.4 injection in a rat model. Anaesthesia. 2015 Sep;70(9):1045-51. doi: 10.1111/anae.13076. Epub 2015 Apr 23.
- Vassal O, Del Carmine P, Desgranges FP, Bouvet L, Lilot M, Gadot N, Timour-Chah Q, Chassard D. Assessment of Neurological Toxicity of Hydroxyethyl Starch 130/0.4 Injected in the Intrathecal Space in Rats. Pain Med. 2018 Oct 1;19(10):2016-2020. doi: 10.1093/pm/pny005.
- 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.
- Fan YT, Zhao TY, Chen JH, Tang YL, Song XR. Prophylactic Epidural Blood Patch or Prophylactic Epidural Infusion of Hydroxyethyl Starch in Preventing Post-Dural Puncture Headache - A Retrospective Study. Pain Physician. 2023 Sep;26(5):485-493.
- Zhou Y, Geng Z, Song L, Wang D. Epidural hydroxyethyl starch ameliorating postdural puncture headache after accidental dural puncture. Chin Med J (Engl). 2023 Jan 5;136(1):88-95. doi: 10.1097/CM9.0000000000001967.
- Binyamin Y, Azem K, Heesen M, Gruzman I, Frenkel A, Fein S, Eidelman LA, Garren A, Frank D, Orbach-Zinger S. The effect of placement and management of intrathecal catheters following accidental dural puncture on the incidence of postdural puncture headache and severity: a retrospective real-world study. Anaesthesia. 2023 Oct;78(10):1256-1261. doi: 10.1111/anae.16088. Epub 2023 Jul 13.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2026R0413-0002
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.