Postdural Puncture HeadacheNCT01977898
Incidence of Headache Following an Unintentional Dural Puncture
A study testing Morphine and Saline in people with Postdural Puncture Headache and Post-Lumbar Puncture Headache, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postdural Puncture Headache, Post-Lumbar Puncture Headache, Cerebrospinal Fluid Leaks
- What is being tested?
- Morphine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postpartum patients following vaginal delivery
- Unintentional dural puncture
- Functioning intrathecal catheter
- Patients must be 18 years of age or older
- English speaking.
Who cannot join
- History of previous PDPH
- Body mass index BMI > 40 kg/m2
- History of obstructive sleep apnea (OSA)
- Morphine allergy
- Patients who receive Cesarean delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Incidence of Post-Dural Puncture Headache Following Unintentional Dural Puncture: A Randomized Trial of Intrathecal Morphine Versus Saline
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.
Read the 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.
- Being tested
- Morphine, Saline
- Keywords
- Postdural puncture headache, Intrathecal morphine, Intrathecal catheter, Headache, Labor and delivery, Unintentional dural puncture
- Medical subject headings
- Post-Dural Puncture Headache, Cerebrospinal Fluid Leak, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called Duramorph
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.
SalineDrug
Also called Normal 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.
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Experimental | Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Receives: Drug: Morphine |
| Saline | Placebo comparator | Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Who Report Post Dural Puncture Headaches
Participants who report post dural puncture headaches from delivery to postpartum day 5
Measured: 5 days
Secondary outcomes (10)
Severity of Post Dural Puncture Headache
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.
Measured: Time of unintentional dural puncture to postpartum day 5
Treatment Method for Headache
Treatment method completed for unintentional dural puncture headache.
Measured: Unintentional dural puncture - Postpartum day 5
Number of Participants With Cranial Nerve Symptoms
The number of participants who experience cranial nerve symptoms up to 5 days after the unintentional dural puncture.
Measured: 5 days
Repeat Epidural Blood Patch
Repeated epidural blood patch for headache pain after unintentional dural puncture.
Measured: After first epidural blood patch to 5 days after delivery
Presenting Day of Headache
Presenting day of headache after unintentional dural puncture
Measured: Dural puncture to 5 days after delivery
Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture.
The duration in days of headaches the participants experience after an unintentional dural puncture
Measured: 5 days
Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture
Greatest reported headache pain associated with unintentional dural puncture reported on a scale of 0= no pain to 10= worst pain imaginable.
Measured: 5 days
Intrathecal Catheter Dwell Time
Intrathecal catheter dwell time(time from insertion to time of removal in minutes).
Measured: Insertion time to removal in minutes
Intrathecal Infusion Volume
Intrathecal infusion volume in milliliters
Measured: Time of insertion of catheter to time catheter removed
Mode of Delivery
Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery)
Measured: up to 10 hours after intrathecal catheter placed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2011
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyce M. Peralta, MD, MS, Northwestern University
- Investigators
- Feyce Peralta, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977898
- Sponsor's protocol ID
- STU00043549
- Status last verified
- Nov 2021
- First submitted
- 31 Oct 2013
- Last updated
- 17 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20682567Denny 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.
PubMed 3605700Choi 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.
PubMed 12734154Choi 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.
PubMed 8826568Hartopp 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.
PubMed 19945855Angle 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.
PubMed 15814755Carbaat 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.
PubMed 6118577Sudlow C, Warlow C. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2002;(2):CD001790. doi: 10.1002/14651858.CD001790.
PubMed 12076420Hakim SM. Cosyntropin for prophylaxis against postdural puncture headache after accidental dural puncture. Anesthesiology. 2010 Aug;113(2):413-20. doi: 10.1097/ALN.0b013e3181dfd424.
PubMed 20613476Carter 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.
PubMed 10638928Ayad 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.
PubMed 14634940Charsley 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.
PubMed 11464346Cohen 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.
PubMed 7839783Scavone 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.
PubMed 15564951Eldor 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.
PubMed 2278354
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Post-Dural Puncture Headache Following Unintentional Dural Puncture: A Randomized Trial of Intrathecal Morphine Versus Saline
- ClinicalTrials.gov ID
- NCT01977898
- Acronym / sponsor ID
- STU00043549
- Keywords
- Postdural puncture headache, Intrathecal morphine, Intrathecal catheter, Headache, Labor and delivery, Unintentional dural puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Posted 2 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Experimental | Drug: MorphinePatients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. |
| Saline | Placebo comparator | Drug: SalinePatients randomized to the control group will receive normal saline 0.3 mL intrathecally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Postpartum patients following vaginal delivery
- Unintentional dural puncture
- Functioning intrathecal catheter
- Patients must be 18 years of age or older
- English speaking.
Key exclusion criteria (5 listed)
- History of previous PDPH
- Body mass index BMI > 40 kg/m2
- History of obstructive sleep apnea (OSA)
- Morphine allergy
- Patients who receive Cesarean delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineAlso: DuramorphThe 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. | Drug | Morphine |
| SalineAlso: Normal SalineThe 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. | Drug | Saline |
Primary outcome
Participants Who Report Post Dural Puncture Headaches
Time frame: 5 days
Participants who report post dural puncture headaches from delivery to postpartum day 5
10 secondary outcomes
Severity of Post Dural Puncture Headache
Time frame: Time of unintentional dural puncture to postpartum day 5
Treatment Method for Headache
Time frame: Unintentional dural puncture - Postpartum day 5
Number of Participants With Cranial Nerve Symptoms
Time frame: 5 days
Repeat Epidural Blood Patch
Time frame: After first epidural blood patch to 5 days after delivery
Presenting Day of Headache
Time frame: Dural puncture to 5 days after delivery
Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture.
Time frame: 5 days
Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture
Time frame: 5 days
Intrathecal Catheter Dwell Time
Time frame: Insertion time to removal in minutes
Intrathecal Infusion Volume
Time frame: Time of insertion of catheter to time catheter removed
Mode of Delivery
Time frame: up to 10 hours after intrathecal catheter placed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20682567Apfel 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.
- Background: PubMed 3605700Denny 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.
- Background: PubMed 12734154Choi 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.
- Background: PubMed 8826568Choi 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.
- Background: PubMed 19945855Hartopp 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.
- Background: PubMed 15814755Angle 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.
- Background: PubMed 6118577Carbaat 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.
- Background: PubMed 12076420Sudlow C, Warlow C. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2002;(2):CD001790. doi: 10.1002/14651858.CD001790.
- Background: PubMed 20613476Hakim SM. Cosyntropin for prophylaxis against postdural puncture headache after accidental dural puncture. Anesthesiology. 2010 Aug;113(2):413-20. doi: 10.1097/ALN.0b013e3181dfd424.
- Background: PubMed 10638928Carter 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.
- Background: PubMed 14634940Ayad 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.
- Background: PubMed 11464346Charsley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feyce Peralta, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine and Saline in people with Postdural Puncture Headache and Post-Lumbar Puncture Headache, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Who Report Post Dural Puncture Headaches (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01977898, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.