Incidence of Headache Following an Unintentional Dural Puncture
Fjalë kyçe
Abstrakt
Përshkrim
Unintentional dural puncture is a known risk of neuraxial techniques, occurring in roughly 1% of all epidural catheter placements. The incidence of post dural puncture headaches(PDPH) after unintentional dural puncture (UDP) is 50-80%. A PDPH is defined as a headache that occurs following a dural puncture, worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying, with at least one of the following: neck stiffness, tinnitus, hypacusia, photophobia, or nausea. The headache develops within 5 days after dural puncture and resolves either spontaneously within 1 week or within 48 hours after effective treatment of the spinal fluid leak.
The rates of PDPH following unintentional dural puncture with placement of an intrathecal catheter will be compared in two groups: intrathecal morphine (treatment) versus intrathecal saline (control) administered 1-2 hours after delivery, followed by immediate catheter removal. Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Those randomized to the control group will receive normal saline 0.3 mL intrathecally. After administration of intrathecal morphine, all patients will have their respirations monitored every hour for a period of 12 hours and then every two hours for a period of 12 hours. On postpartum days 1-5, all patients will be visited daily while inpatient and/or contacted by phone after discharge from the hospital.
PDPH can lead to significant morbidity and negatively impact patient satisfaction with postpartum recovery. Along with headache, patients may develop cranial nerve palsy during the postpartum period leading to permanent disability. In addition, new mothers are unable to bond with their babies due to headache and associated symptoms of nausea, vomiting and limited mobility secondary to pain. Therefore, an effective intervention to decrease the risk of PDPH after UDP would be useful.
Datat
| Verifikuar së fundmi: | 02/28/2019 |
| Paraqitur së pari: | 10/30/2013 |
| Regjistrimi i vlerësuar u dorëzua: | 10/30/2013 |
| Postuar së pari: | 11/06/2013 |
| Përditësimi i fundit i paraqitur: | 03/12/2019 |
| Përditësimi i fundit i postuar: | 03/13/2019 |
| Data e fillimit të studimit aktual: | 10/31/2011 |
| Data e vlerësuar e përfundimit primar: | 02/28/2019 |
| Data e vlerësimit të përfundimit të studimit: | 02/28/2019 |
Gjendja ose sëmundja
Ndërhyrja / trajtimi
Drug: Morphine
Drug: Saline
Faza
Grupet e krahëve
| Krah | Ndërhyrja / trajtimi |
|---|---|
| Experimental: Morphine Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. | Drug: Morphine The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection. |
| Placebo Comparator: Saline Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. | Drug: Saline The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection. |
Kriteret e pranimit
| Moshat e pranueshme për studim | 18 Years Për të 18 Years |
| Gjinitë e pranueshme për studim | Female |
| Pranon Vullnetarë të Shëndetshëm | po |
| Kriteret | Inclusion Criteria: - Postpartum patients following vaginal delivery - Unintentional dural puncture - Functioning intrathecal catheter - Patients must be 18 years of age or older - English speaking. Exclusion Criteria: - History of previous PDPH - Body mass index BMI > 40 kg/m2 - History of obstructive sleep apnea (OSA) - Morphine allergy - Patients who receive Cesarean delivery |
Rezultati
Masat Kryesore të Rezultateve
1. Incidence of post dural puncture headaches [Delivery - postpartum day 5]
Masat dytësore të rezultateve
1. Severity of headache [Delivery - Postpartum day 5]
2. Need for Epidural Blood Patch [Delivery - Postpartum day 5]
