- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01977898
Incidence of Headache Following an Unintentional Dural Puncture
Incidence of Post-Dural Puncture Headache Following Unintentional Dural Puncture: A Randomized Trial of Intrathecal Morphine Versus Saline
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Morphine
Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.
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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.
Other Names:
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Placebo Comparator: Saline
Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants Who Report Post Dural Puncture Headaches
Time Frame: 5 days
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Participants who report post dural puncture headaches from delivery to postpartum day 5
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5 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of Post Dural Puncture Headache
Time Frame: Time of unintentional dural puncture to postpartum day 5
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Severity of post dural puncture headache on a numerical rating scale 0= no pain and 10= worst pain imaginable from the time of delivery to postpartum day 5.
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Time of unintentional dural puncture to postpartum day 5
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Treatment Method for Headache
Time Frame: Unintentional dural puncture - Postpartum day 5
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Treatment method completed for unintentional dural puncture headache.
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Unintentional dural puncture - Postpartum day 5
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Number of Participants With Cranial Nerve Symptoms
Time Frame: 5 days
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The number of participants who experience cranial nerve symptoms up to 5 days after the unintentional dural puncture.
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5 days
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Repeat Epidural Blood Patch
Time Frame: After first epidural blood patch to 5 days after delivery
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Repeated epidural blood patch for headache pain after unintentional dural puncture.
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After first epidural blood patch to 5 days after delivery
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Presenting Day of Headache
Time Frame: Dural puncture to 5 days after delivery
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Presenting day of headache after unintentional dural puncture
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Dural puncture to 5 days after delivery
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Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture.
Time Frame: 5 days
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The duration in days of headaches the participants experience after an unintentional dural puncture
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5 days
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Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture
Time Frame: 5 days
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Greatest reported headache pain associated with unintentional dural puncture reported on a scale of 0= no pain to 10= worst pain imaginable.
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5 days
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Intrathecal Catheter Dwell Time
Time Frame: Insertion time to removal in minutes
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Intrathecal catheter dwell time(time from insertion to time of removal in minutes).
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Insertion time to removal in minutes
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Intrathecal Infusion Volume
Time Frame: Time of insertion of catheter to time catheter removed
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Intrathecal infusion volume in milliliters
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Time of insertion of catheter to time catheter removed
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Mode of Delivery
Time Frame: up to 10 hours after intrathecal catheter placed
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Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery)
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up to 10 hours after intrathecal catheter placed
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Feyce Peralta, MD, Northwestern University
Publications and helpful links
General Publications
- Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460-9. doi: 10.1007/BF03021057.
- Carter BL, Pasupuleti R. Use of intravenous cosyntropin in the treatment of postdural puncture headache. Anesthesiology. 2000 Jan;92(1):272-4. doi: 10.1097/00000542-200001000-00043. No abstract available.
- Angle P, Tang SL, Thompson D, Szalai JP. Expectant management of postdural puncture headache increases hospital length of stay and emergency room visits. Can J Anaesth. 2005 Apr;52(4):397-402. doi: 10.1007/BF03016283.
- Apfel CC, Saxena A, Cakmakkaya OS, Gaiser R, George E, Radke O. Prevention of postdural puncture headache after accidental dural puncture: a quantitative systematic review. Br J Anaesth. 2010 Sep;105(3):255-63. doi: 10.1093/bja/aeq191. Epub 2010 Aug 3.
- Denny N, Masters R, Pearson D, Read J, Sihota M, Selander D. Postdural puncture headache after continuous spinal anesthesia. Anesth Analg. 1987 Aug;66(8):791-4. No abstract available.
- Choi A, Laurito CE, Cunningham FE. Pharmacologic management of postdural puncture headache. Ann Pharmacother. 1996 Jul-Aug;30(7-8):831-9. doi: 10.1177/106002809603000722.
- Hartopp R, Hamlyn L, Stocks G. Ten years of experience with accidental dural puncture and post-dural-puncture headache in a tertiary obstetric anaesthesia department. Int J Obstet Anesth. 2010 Jan;19(1):118. doi: 10.1016/j.ijoa.2009.06.004. Epub 2009 Nov 28. No abstract available.
- Carbaat PA, van Crevel H. Lumbar puncture headache: controlled study on the preventive effect of 24 hours' bed rest. Lancet. 1981 Nov 21;2(8256):1133-5. doi: 10.1016/s0140-6736(81)90586-9. No abstract available.
- Sudlow C, Warlow C. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2002;(2):CD001790. doi: 10.1002/14651858.CD001790.
- Hakim SM. Cosyntropin for prophylaxis against postdural puncture headache after accidental dural puncture. Anesthesiology. 2010 Aug;113(2):413-20. doi: 10.1097/ALN.0b013e3181dfd424.
- Ayad S, Demian Y, Narouze SN, Tetzlaff JE. Subarachnoid catheter placement after wet tap for analgesia in labor: influence on the risk of headache in obstetric patients. Reg Anesth Pain Med. 2003 Nov-Dec;28(6):512-5. doi: 10.1016/s1098-7339(03)00393-6.
- Charsley MM, Abram SE. The injection of intrathecal normal saline reduces the severity of postdural puncture headache. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):301-5. doi: 10.1053/rapm.2001.22584.
- Cohen S, Amar D, Pantuck EJ, Singer N, Divon M. Decreased incidence of headache after accidental dural puncture in caesarean delivery patients receiving continuous postoperative intrathecal analgesia. Acta Anaesthesiol Scand. 1994 Oct;38(7):716-8. doi: 10.1111/j.1399-6576.1994.tb03983.x.
- Scavone BM, Wong CA, Sullivan JT, Yaghmour E, Sherwani SS, McCarthy RJ. Efficacy of a prophylactic epidural blood patch in preventing post dural puncture headache in parturients after inadvertent dural puncture. Anesthesiology. 2004 Dec;101(6):1422-7. doi: 10.1097/00000542-200412000-00024.
- Eldor J, Gozal Y, Lavie A, Guedj P. Late postspinal headache treated with epidural morphine. Anaesthesia. 1990 Dec;45(12):1099. doi: 10.1111/j.1365-2044.1990.tb14936.x. No abstract available.
- Al-metwalli RR. Epidural morphine injections for prevention of post dural puncture headache. Anaesthesia. 2008 Aug;63(8):847-50. doi: 10.1111/j.1365-2044.2008.05494.x. Epub 2008 Jun 10.
- Banks S, Paech M, Gurrin L. An audit of epidural blood patch after accidental dural puncture with a Tuohy needle in obstetric patients. Int J Obstet Anesth. 2001 Jul;10(3):172-6. doi: 10.1054/ijoa.2000.0826.
- Olesen J, Steiner TJ. The International classification of headache disorders, 2nd edn (ICDH-II). J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):808-11. doi: 10.1136/jnnp.2003.031286.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Craniocerebral Trauma
- Trauma, Nervous System
- Headache Disorders
- Headache Disorders, Secondary
- Wounds and Injuries
- Headache
- Post-Dural Puncture Headache
- Cerebrospinal Fluid Leak
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Morphine
Other Study ID Numbers
- STU00043549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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