Long Term Outcomes Following a Post Dural Puncture Headache

NCT03550586 | Completed

• 1 other identifier: 0536-17-RMC
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

Epidural analgesia is considered a gold standard method for treatment of labor pain. One of the major risks with epidural analgesia is an accidental dural puncture, which leads to a post dural puncture headache. This headache is associated with significant maternal morbidity and can result in severe maternal consequences. Post traumatic stress disorder (PTSD) is defined as an anxiety syndrome, resulting from a traumatic experience. Postpartum PTSD, is a form of PTSD that can occur in relation to a traumatic birth experience. As PDPH is unexpected and can cause severe maternal sequele, PDPH can exhibit a posttraumatic stress response. Therefore we hypothesize that parturients who suffered from a PDPH are at higher risk for developing PP-PTSD. To date, very few reports have examined the long term outcomes of parturients suffering from a PDPH. As a follow up to the national survey of PDPH management in Israel the investigators aim, in this prospective multi center, observational study, to evaluate the long term outcomes of parturients suffering from a PDPH, including chronic headache, backache, postpartum depression, decreased breastfeeding and the development of PP PTSD.

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• Post Traumatic Stress Disorder (PTSD) questionnaire score

  The total PTSD questionnaire score using the validated PTSD questionnaire

  Up to ten years postpartum (Answer at telephone survey)

Secondary Outcomes (3)

• The total Edinburgh Postnatal Depression Scale (EPDS) questionnaire score

  Up to ten years postpartum (Answer at telephone survey)

• The total score on the Brief Pain Inventory questionnaire

  Up to ten years postpartum (Answer at telephone survey)

• The total score on the Oswestry low back pain questionnaire

  Up to ten years postpartum (Answer at telephone survey)

Study Arms (2)

Parturients suffering from a PDPH

Parturients suffering form a PDPH following an accidental dural puncture between the years 2007-2017 will be contacted by phone and verbal consent will be obtained for participation in the study. All participants will be requested to answer an IRB approved telephone script. Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire.Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire

Other: Questionaires

Parturients not suffering from a PDPH

This group will consistent of a control group of women receiving epidural analgesia on the same day as those women who suffered an ADP. This participants will be contacted by phone and verbal consent will be obtained for participation in the study. All participants will be requested to answer an IRB approved telephone script. Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire.Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire

Other: Questionaires

Interventions

Questionaires OTHER

Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS)translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire . Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire .

Parturients not suffering from a PDPH; Parturients suffering from a PDPH

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women who developed a PDPH following an ADP between the years 2007-2017 at rabin medical center and at Assaf Harofeh Medical Center.

You may qualify if:

• \- All cases of parturients suffering from a PDPH during the years 2007-2017.

You may not qualify if:

• \- Women unable to be answer a questionnaire in Hebrew. Women under the age 18 Women suffering from a PDPH following spinal anesthesia for cesarean section.

Sponsors & Collaborators

• Rabin Medical Center: lead
• Assaf-Harofeh Medical Center: collaborator

Study Sites (2)

Dr. Chatuib Zoya

Be’er Ya‘aqov, Israel

Location

Beilinson hospital

Petach Tikvah, Israel

Location

Related Publications (11)

• Bradbury CL, Singh SI, Badder SR, Wakely LJ, Jones PM. Prevention of post-dural puncture headache in parturients: a systematic review and meta-analysis. Acta Anaesthesiol Scand. 2013 Apr;57(4):417-30. doi: 10.1111/aas.12047. Epub 2012 Dec 28.

  PMID: 23278515 BACKGROUND

• Sachs A, Smiley R. Post-dural puncture headache: the worst common complication in obstetric anesthesia. Semin Perinatol. 2014 Oct;38(6):386-94. doi: 10.1053/j.semperi.2014.07.007. Epub 2014 Aug 19.

  PMID: 25146108 BACKGROUND

• Arevalo-Rodriguez I, Ciapponi A, Roque i Figuls M, Munoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009199. doi: 10.1002/14651858.CD009199.pub3.

  PMID: 26950232 BACKGROUND

• 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.

  PMID: 15814755 BACKGROUND

• Webb CA, Weyker PD, Zhang L, Stanley S, Coyle DT, Tang T, Smiley RM, Flood P. Unintentional dural puncture with a Tuohy needle increases risk of chronic headache. Anesth Analg. 2012 Jul;115(1):124-32. doi: 10.1213/ANE.0b013e3182501c06. Epub 2012 Mar 30.

  PMID: 22467897 BACKGROUND

• Shah R, Kubisz-Pudelko A, Reid J. Posterior reversible encephalopathy syndrome following an inadvertent dural puncture during an emergency laparotomy for ischemic colitis - a case report. Local Reg Anesth. 2014 Jan 20;7:1-4. doi: 10.2147/LRA.S57660. eCollection 2014.

  PMID: 24600245 BACKGROUND

• Gomez-Rios MA, Fernandez-Goti MC. Pneumocephalus after inadvertent dural puncture during epidural anesthesia. Anesthesiology. 2013 Feb;118(2):444. doi: 10.1097/ALN.0b013e31825e6ecc. No abstract available.

  PMID: 22692380 BACKGROUND

• Liang MY, Pagel PS. Bilateral interhemispheric subdural hematoma after inadvertent lumbar puncture in a parturient. Can J Anaesth. 2012 Apr;59(4):389-93. doi: 10.1007/s12630-011-9664-6. Epub 2012 Jan 4.

  PMID: 22215524 BACKGROUND

• Basurto Ona X, Uriona Tuma SM, Martinez Garcia L, Sola I, Bonfill Cosp X. Drug therapy for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD001792. doi: 10.1002/14651858.CD001792.pub3.

  PMID: 23450533 BACKGROUND

• Stannard D. Epidural blood patching for preventing and treating postdural puncture headache. J Perianesth Nurs. 2011 Dec;26(6):411-2. doi: 10.1016/j.jopan.2011.09.002. No abstract available.

  PMID: 22099135 BACKGROUND

• 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.

  PMID: 32858584 DERIVED

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sharon O Zinger

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: June 8, 2018
• Study Start: April 24, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 24, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)