Clinical trial NCT01977898
Conditions: Postdural Puncture Headache Post-Lumbar Puncture Headache Cerebrospinal Fluid Leaks
Keywords: Postdural puncture headache Intrathecal morphine Intrathecal catheter Headache Labor and delivery Unintentional dural puncture
Sponsor: Northwestern University
Start date: 2011-11-01; Completion date: 2019-03-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the use of intrathecal morphine administration following an unintentional dural puncture, to decrease the incidence of post dural puncture headaches (PDPH) in obstetric patients.

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.

Arms: arm 1: Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. arm 2: Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.
Interventions: intervention 1: Morphine intervention 2: Saline
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents:
Prot_SAP_000.pdf: 
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Northwestern University Feinberg School of Medicine  
Department of Anesthesiology  
 
 
 
 
 
 
Protocol 
 
Title:  Incidence of Post-Dural Puncture Headache following Unintentional Dural Puncture: A Randomized 
Trial of Intrathecal Morphine versus Saline  
 
 
Principal Investigator: Feyce Peralta, M.D. Co-investigator (s):  Robert McCarthy, PharmD 
 
Affiliation: Department of Anesthesiology 
                    Northwestern University Feinberg School of Medicine 
 
Institution: Northwestern Memorial Hospital 
Research Aims:  
 
1. Research Questions(s):  Does the administration of intrathecal morphine after delivery reduce the 
risk of post-dural puncture headache (PDPH) following unintentional dural puncture (UDP) with a 
17-g Tuohy needle in obstetric patients?   
 
2. Hypotheses:  Intrathecal morphine decreases the incidence of PDPH as compared to placebo after 
UDP with a Tuohy needle in obstetric patients. 
 
Background:  Unintentional dural puncture is a known risk of neuraxial techniques, occurring in roughly 
1% of all epidural catheter placements.1-3  The incidence of PDPH after unintentional dural puncture is 50-
80%.3-5  The International Headache Society has defined PDPH 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 (usually by epidural blood patch).6  PDPH can be a 
significant cause of maternal morbidity in the obstetric patient.  In addition to interfering with the mother’s 
ability to care for her newborn, treatment of PDPH can increase health care costs by prolonging the length 
of hospitalization and number of emergency room visits.7   
Several strategies exist to treat PDPH, but currently there are no proven interventions for preventing or 
reducing the likelihood of PDPH following unintentional dural puncture.8,9 Previously investigated 
strategies include prophylactic epidural blood patch, the use of intrathecal (IT) catheter with delayed 
removal, intrathecal saline injection and infusion, and cosyntropin administration.10-15  Retrospective and 
observational studies have demonstrated a decrease in PDPH rates following unintentional dural puncture 
when intrathecal catheters are placed instead of subsequent placement of an epidural catheter.1,12  Other 
observational studies have examined the use of intrathecal opioids to reduce the incidence of PDPH.14,16  
Recently, one randomized controlled trial explored the use of epidural morphine for the prevention and 
treatment of PDPH with positive results. Al-metwalli showed a decrease in the PDPH rate from 48% to 
12% after administration of epidural morphine 3 mg at the time of delivery and again at 24 hours 
postpartum.17  Administration of epidural morphine following UDP may produce unpredictable central 
nervous system side effects, however, as a large dural hole may facilitate intrathecal translocation of 
epidural morphine, increasing the risk of respiratory depression.  At our institution, it is common practice 
for an intrathecal catheter to be placed after UDP instead of an epidural catheter at another spinal level. 
Given that the administration of epidural morphine after known UDP may have unpredictable effects and 
that the use of intrathecal catheters following UDP is a common practice, we feel it is necessary to study 
the use of intrathecal morphine administration following UDP to decrease the incidence of PDPH.  In our 
randomized prospective study, the rates of PDPH following unintentional dural puncture with placement 
of an intrathecal catheter will be compared in two groups:  intrathecal morphine versus intrathecal saline 


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administration 1-2 hours after delivery followed by immediate catheter removal.  We have chosen to 
administer intrathecal morphine 150 μg as this is the current dose given to parturients receiving morphine 
via spinal administration for Cesarean delivery and has a predictable side effect profile and history of safety 
in this population.  The dose roughly corresponds to the epidural morphine dose administered by Al-
metwalli in his randomized controlled trial.17       
 
1. 
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;105:255-63. PMID: 
20682567 
2. 
Denny N, Masters R, Pearson D, Read J, Sihota M, Selander D. Postdural puncture headache after continuous 
spinal anesthesia. Anesth Analg 1987;66:791-4. PMID: 3605700 
3. 
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;50:460-9. PMID: 
12734154 
4. 
Choi A, Laurito CE, Cunningham FE. Pharmacologic management of postdural puncture headache. Ann 
Pharmacother 1996;30:831-9. PMID: 8826568 
5. 
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;19:118. PMID: 19945855 
6. 
Olesen J, Steiner TJ. The International classification of headache disorders, 2nd edn (ICDH-II). J Neurol 
Neurosurg Psychiatry 2004;75:808-11. PMID: 1739053 
7. 
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;52:397-402. PMID: 15814755 
8. 
Carbaat PA, van Crevel H. Lumbar puncture headache: controlled study on the preventive effect of 24 hours' 
bed rest. Lancet 1981;2:1133-5. PMID: 6118577 
9. 
Sudlow C, Warlow C. Posture and fluids for preventing post-dural puncture headache. Cochrane Database 
Syst Rev 2002:CD001790. PMID: 12076420 
10. 
Hakim SM. Cosyntropin for prophylaxis against postdural puncture headache after accidental dural puncture. 
Anesthesiology 2010;113:413-20. PMID: 20613476 
11. 
Carter BL, Pasupuleti R. Use of intravenous cosyntropin in the treatment of postdural puncture headache. 
Anesthesiology 2000;92:272-4. PMID: 10638928 
12. 
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;28:512-5. PMID: 14634940 
13. 
Charsley MM, Abram SE. The injection of intrathecal normal saline reduces the severity of postdural 
puncture headache. Reg Anesth Pain Med 2001;26:301-5. PMID: 11464346 
14. 
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;38:716-8. PMID: 7839783 
15. 
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;101:1422-7. PMID: 15564951 
16. 
Eldor J, Guedj P, Cotev S. Epidural morphine injections for the treatment of postspinal headache. Can J 
Anaesth 1990;37:710-1. PMID: 2278354 
17. 
Al-metwalli RR. Epidural morphine injections for prevention of post dural puncture headache. Anaesthesia 
2008;63:847-50. PMID: 18547293 
18. 
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;10:172-6. PMID: 15321606 
 
 
Significance:  PDPH can lead to significant morbidity.  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 including nausea, vomiting and 
limited mobility secondary to pain.  PDPH can negatively impact patient satisfaction with postpartum 
recovery.   Therefore, an effective intervention to decrease the risk of PDPH after UDP would be useful. 
 
 


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Investigational Plan: 
 
Study design: prospective, randomized-controlled, blinded study 
 
Methods: 
1. Size of study groups(s):   
The incidence of PDPH has been estimated to approximately 50% after unintentional dural puncture.18 
Assuming that a decrease of at least 50% would be necessary to suggest a clinical utility of this treatment, 
we determined that a sample size of 64 patients in each group would be required to achieve an 80% power 
to detect this difference between epidural and intrathecal catheter.  Group sample sizes of 64 achieve 80% 
power to detect a difference between the group proportions of 0.25. The proportion in group one (the 
treatment group) is assumed to be 0.5 under the null hypothesis and 0.25 under the alternative hypothesis. 
The proportion in group two (the control group) is 0.5. The test statistic used is the two-sided Fisher's exact 
test. The significance level of the test was targeted at 0.05. The significance level actually achieved by this 
design is 0.03.  Sample size was calculated using PASS 11, version 11.0.01, release date 11/3/2010 (NCSS 
Inc. Kaysville, UT). To account for protocol exclusions and patients lost to follow-up, 170 patients will be 
randomized.  Recruitment for this project will take roughly 1-2yrs. 
 
2. Patient entry, exclusion and dropout criteria: 
Inclusion:  Postpartum patients following vaginal delivery with an unintentional dural puncture and 
functioning intrathecal catheter.  Patients must be 18 years of age or older and English speaking. 
Exclusion:  Previous PDPH, body mass index BMI>40 kg/m2, obstructive sleep apnea (OSA), morphine 
allergy and patients who receive Cesarean delivery (as these patients would all receive intrathecal morphine 
and could therefore not be randomized).   
 
3. Protocol specific methods:  Eligible patients will be asked by anesthesia personnel to participate in this 
study shortly following delivery when the nurse taking care of the patient deems the patient appropriate for 
discharge.  Informed, written consent will be obtained and the pharmacy on the 10th floor Prentice Women’s 
Hospital  will determine group allocation by randomization table.  The patient will be randomized to one 
of two groups:  intrathecal morphine (treatment) vs. saline (control) which will be administered through the 
existing intrathecal catheter.  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.   The drugs will be prepared in  syringes by a pharmacist on the 
10th floor Prentice Women’s Hosptial  and labeled as “IT morphine study drug.”  The anesthesiologist 
injecting the study drug, the study nurse collecting follow-up data, and the patient will be blinded to group 
assignment. 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.  If the 
anesthesiologist is unable to aspirate from the catheter, the intrathecal drug will be administered and flushed 
with 1.0 mL of preservative free saline to ensure drug delivery.  The inability to aspirate will be noted on 
the data sheet at the time of administration.  Sterile gloves will be used for all morphine or saline 
administration.   
 
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.  This is standard protocol after 
the administration of neuraxial morphine at NMH.  If the patient develops symptoms of nausea, vomiting, 
urinary retention or pruritus, she will receive standard interventions per the NMH order-set for neuraxial 
opioids.   


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On postpartum days 1-5, all patients will be visited daily while inpatient and called by phone after discharge 
from the hospital.  The following information will be also recorded in this study: presence or absence of 
PDPH (as defined by the International Headache Society), signs and symptoms of cranial nerve injury, the 
patient’s verbal rating score for pain (VRSP, 0-10 scale), current headache treatments including oral 
analgesics, intravenous caffeine, or epidural blood patch, side effects of intrathecal morphine (respiratory 
depression, nausea, vomiting, pruritus, urinary retention.  Patients who develop a headache will be followed 
for 3 days after the resolution of their headache.  Physician observers will make treatment recommendations 
according to the following protocol (previously described by Scavone et al, 200415):  Mild postural 
headaches (defined as VRSP <4) will be treated with conservative therapy including oral hydration, 
increased oral caffeine intake, and oral analgesics as needed.  Moderate postural headaches (defined as 
VRSP 4-6 without limitation of childcare ability) will also receive conservative therapy.  Patients with 
moderate postural headaches limiting childcare abilities, and patients complaining of severe postural 
headaches (defined as VRSP >6) will be advised to undergo a therapeutic epidural blood patch (EBP).  This 
treatment will consist of the epidural injection of 20 mL of autologous blood over 2 to 3 min through the 
epidural needle, injected at the level of the presumed UDP or one level below.  The patient will be 
positioned in the sitting position for the procedure and then repositioned supine for a period of 1 hour after 
the epidural blood injection.  The EBP will not be performed for at least 24 hours after dural puncture.  If 
the EBP fails to relieve the headache after 24 hours, or if the headache recurs after successful treatment, the 
EBP may be repeated.  The protocol outlined above follows standard procedure at NMH. 
 
4. Risks/Benefits:   
Risks to study patients include: itching, nausea, vomiting, urinary retention, constipation, dizziness, 
hypotension, depression of cough reflex and slowing of respirations. The rare risk is respiratory depression 
leading to respiratory arrest.   
 
The presumed risks are similar to that assumed by any parturient who receives spinal morphine for Cesarean 
delivery, which is common practice.  To minimize the risk of apnea, patient will be monitored postpartum 
in the same manner that patients receiving neuraxial morphine for Cesarean delivery are routinely 
monitored as described above.   
 
 If any patient experiences nausea, vomiting or pruritus, she will be treated with medications based on the 
clinical scenario as evaluated by the attending anesthesiologist on duty who will not be blinded to treatment 
group. There is also a risk of loss of confidentiality.   
 
Confidentiality: Access to electronic data is computer password protected. All data will be deleted from 
the password protected computer 5 years after manuscript preparation. Electronic and paper documents will 
be destroyed using current technology. The paper documents will be shredded using the current vendor for 
HIPAA sensitive documents using the current technique. 
 
 
Data Analysis: 
1. 
Data collection form:  Data collection form attached. 
 
2. 
Data evaluation:  The primary outcome is the incidence of PDPH.  The intrathecal morphine and 
saline groups will be compared using the Fisher’s exact test.  The clinical characteristics of the study groups 
will be compared between groups using the Mann Whitney test for interval and continuous data and a χ2 
statistic for nominal data. Secondary outcomes include severity of headache, need for epidural blood patch, 
rate of neuraxial infection, neuraxial complications.  P < 0.05 will be required to reject the null hypothesis. 
 


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3. 
Interpretation of Anticipated Results:  A reduced incidence of PDPH in the intrathecal morphine 
group without an unacceptable incidence of side effects would support the effectiveness its administration 
after UDP. 
 
Budget: 
1. Materials:  Preservative free morphine (2-mL) 1000 microgram ampule – cost 80 cents per vial 
for 64 patients.   Preservative free 0.9% saline (10-mL) vial – cost 35 cents per vial for 64 patients.  
The total cost for study drugs is $74.75, which will be provided by the Department of 
Anesthesiology. 
 
2. Labor Requirements:  Obstetric anesthesiology research nurses and obstetric anesthesiology 
fellows will recruit patients for the study and will perform all data collection. 
 
3. Presentation Cost:  This project will be presented at a national meeting such as ASA or SOAP. 
 
Consent:  (Provide a consent form in the relevant IRB format.  The template for these forms can be found 
on the Web at: http://www.research.northwestern.edu/oprs/irb/templates/ 
 
Additional information for preparation of an IRB Submission: 
  NA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Incidence of post-dural puncture headache following unintentional dural puncture: a randomized trial of 
intrathecal morphine vs. saline 


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DATA COLLECTION FORM 
 
 
     Study Number:_________________  
 
   Date: ______________   
 
     EGA:______________  
 
 
   Parity:_____________ 
   
     Height (inches):__________________ 
       
   Weight (kilogram):_______                                            
 
     Procedure performed by:__________ 
 
    If resident/fellow specify level of training PGY-_______ 
 
    Loss of Resistance -  air   /   saline   
 
 
    Dural puncture interspace - _______________ 
 
    Intrathecal Catheter Placement: 
Date________   Time______ 
Location (skin)____cm 
 
    Intrathecal Catheter Removal:     Date_______   Time _______ 
Location (skin)____cm 
 
    Total infusion dose:  _____________mLs 
 
    Mode of delivery -   Vaginal    / Forceps or Vacuum Assisted 
 
    Start of pushing - ________________             End of pushing - _______________ 
 
    Delivery time - ____________________          Time of removal of catheter __________________ 
 
 
    Aspirate of CSF prior to drug administration -    yes  /   no 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Incidence of post-dural puncture headache following unintentional dural puncture: a randomized 
trial of intrathecal morphine vs. saline 
 


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Patient Study Number _______________ 
Postpartum day #  _______     
Evaluator:________________        
Date:___________      Time:____________Presence  of  PDPH   yes   /    no 
If yes, Headache VPRS score (1-10):0   1   2   3   4   5   6   7   8   9   10 
 
 
Current Headache therapy (please circle and specify doses when appropriate) 
1. Hydration  __________________________ 
2. Oral analgesics _____________________________ 
3. IV analgesics ________________________________ 
4. IV Caffeine ___________________________________ 
5. Epidural blood patch  date -___________________________ 
                         (please fill out EBP data sheet with details) 
 
Headache VPRS score after treatment______ 
 
 
Cranial nerve involvement -     yes  /   no 
If yes, please specify____________ 
 
Presence of backache -    yes  /   no 
Backache VPRS score0   1   2   3   4   5   6   7   8   9   10 
 
Signs/symptoms of infection 
   1.  Max Fever in last 24hours_______________ 
   2.  Superficial (i.e., swelling, redness, purulence around site     yes  / no     What? _____________ 
   3.  CNS (i.e., meningitis, epidural abscess) 
            ___________________________________________________________ 
 
Lower extremity peripheral nerve symptoms 
      1. Weakness (where)  ______________________ 
       2.  Paresthesia (where) ________________________________ 
 
 
Recommended Therapy (please circle all that apply) 
1. Hydration 
2. Oral analgesics 
3. IV analgesics  
4. IV Caffeine 
5. Epidural blood patch 
 
 
 
 
 


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Unintentional dural puncture headache
Patients that have an intrathecal catheter in place will be offered 
enrollment in study
Intrathecal morphine
0.3mL of Morphine (150 mcg)
Intrathecal  saline
0.3mL of saline
F/U for at least 5 days after catheter removal
Daily visits while inpatient
Daily phone phone calls after discharge
If patient develops headache will be followed  for three days following 
resolution of headache
Exclusion:
Previous PDPH
BMI >40
OSA
Morphine allergy
Cesarean delivery