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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Zhi-Yu Geng, MD
- Puhelinnumero: 86 10 83572460
- Sähköposti: gengzhiyu2013@163.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Dong-Xin Wang, MD, PhD
- Puhelinnumero: 86 10 83572784
- Sähköposti: wangdongxin@hotmail.com
Opiskelupaikat
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Beijing Municipality
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Beijing, Beijing Municipality, Kiina, 100034
- Peking University First Hospital
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Ottaa yhteyttä:
- Zhi-Yu Geng, MD
- Puhelinnumero: 010-83572460
- Sähköposti: gengzhiyu2013@163.com
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Beijing, Beijing Municipality, Kiina, 100080
- Beijing Haidian Maternal and Child Health Hospital
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Ottaa yhteyttä:
- Bo Lei, MD
- Sähköposti: Leibo1977@163.com
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Ningxia
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Yinchuan, Ningxia, Kiina, 750001
- Ningxia Maternal and Child Health Hospital
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Ottaa yhteyttä:
- Hong-Ping Li, MD
- Sähköposti: 1395078537@163.com4
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Shanxi
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Taiyuan, Shanxi, Kiina, 030009
- Taiyuan central hospital
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Ottaa yhteyttä:
- Jian-Ying Ding, MD
- Sähköposti: dingjianying-2004@163.com
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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.
Muut nimet:
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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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Incidence of post-dural puncture headache (PDPH) within 7 days.
Aikaikkuna: 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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Duration of post-dural puncture headache (PDPH)
Aikaikkuna: 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)
Aikaikkuna: 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.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Dong-Xin Wang, MD, PhD, Peking University First Hospital
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
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- 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.
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- 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.
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- 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.
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Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
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