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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Zhi-Yu Geng, MD
- Telefonní číslo: 86 10 83572460
- E-mail: gengzhiyu2013@163.com
Studijní záloha kontaktů
- Jméno: Dong-Xin Wang, MD, PhD
- Telefonní číslo: 86 10 83572784
- E-mail: wangdongxin@hotmail.com
Studijní místa
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Čína, 100034
- Peking University First Hospital
-
Kontakt:
- Zhi-Yu Geng, MD
- Telefonní číslo: 010-83572460
- E-mail: gengzhiyu2013@163.com
-
Beijing, Beijing Municipality, Čína, 100080
- Beijing Haidian Maternal and Child Health Hospital
-
Kontakt:
- Bo Lei, MD
- E-mail: Leibo1977@163.com
-
-
Ningxia
-
Yinchuan, Ningxia, Čína, 750001
- Ningxia Maternal and Child Health Hospital
-
Kontakt:
- Hong-Ping Li, MD
- E-mail: 1395078537@163.com4
-
-
Shanxi
-
Taiyuan, Shanxi, Čína, 030009
- Taiyuan central hospital
-
Kontakt:
- Jian-Ying Ding, MD
- E-mail: dingjianying-2004@163.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
Ostatní jména:
|
|
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of post-dural puncture headache (PDPH) within 7 days.
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Duration of post-dural puncture headache (PDPH)
Časové okno: 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)
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Dong-Xin Wang, MD, PhD, Peking University First Hospital
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026R0413-0002
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .