EPiMAP Obstetrics European Practices in the Management of Accidental Dural Puncture in Obstetrics

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Appendix 2: Case Report Form EPiMAP Obstetrics European Practices in the Management of Accidental Dural Puncture in Obstetrics Case Report Form Please fill each relevant step carefully Step 1.

1 Appendix 2: Case Report Form EPiMAP Obstetrics European Practices in the Management of Accidental Dural Puncture in Obstetrics Case Report Form Please fill each relevant step carefully Step 1. From Epidural (EDA) insertion to confirmed diagsis of post-dural puncture headache (PDPH) including initial management 1 2 Study Subject ID: Informed consent applicable? 2.1 If, was consent obtained? 2.2 If obtained, enter date of signature for Informed Consent 3 Age: years [18-60] 4 Number of previous deliveries: [0-9] 5 Height: cm [ ] 6 Weight: kg [30-200] 7 Is there any history of (more than one alternative possible): 8 Is the patient a smoker? - - format xxx-xxx-xxx 3 digit code for the country, 3 digit code for the hospital and 3 digit individual patient number, separated with hyphens (choose if consent process has been confirmed in writing as t needed by local Ethics) - - [>=01-Jan-2016] format dd-mmm-yyyy (Month in English starting with capital letter) Neuraxial anaesthesia Post-dural puncture headache (PDPH) hronic headache igraine Vertebral column pathology (herniated disc, scoliosis etc.) Chronic backache Administration What best describes the occupation of the patient? What is the highest education of the patient? Mode of delivery: mechanic, building industry, driver, etc.) unemployed Page 1 of 10

2 When was Epidural (EDA) inserted? Exact day: Time of day: Diameter of Tuohy/other needle used for EDA insertion: Media for detecting loss of resistance: (select single) Position of patient at insertion of EDA (when accidental dural puncture occurred) Level of insertion of EDA: (when accidental dural puncture occurred) Technical difficulties in insertion: (obesity, previous surgery, scoliosis etc.) Multiple attempts made at inserting epidural needle at different levels: Was the catheter placed intrathecally following ADP? What is the experience of the "operator" (anaesthesiologist) in the profession? How was the accidental dural puncture (ADP) determined? (more than one alternative possible) If ather attempt to establish epidural anaesthesia, did ather ADP occur? Was ather epidural successfully established in the end? Was a prophylactic epidural blood patch (EBP) performed after delivery? How many hours after ADP did the patients develop symptoms of PDPH? When was the PDPH diagsis confirmed by an anaesthesiologist? What were the presenting symptoms other than classical PDPH? (more than one alternative possible) Was any conservative treatment initiated before a definite diagsis by an anaesthesiologist? : HH:MM [0-23] hrs [0-59] min 16 G 17 G 18 G G G air saline both (air & saline) acoustic technique lying (lateral) sitting L1-2 L2-3 L < 6 months 6 months - 1 year 1-5 years 20.1 if, how much time was the catheter left intrathecally: hours [0-48] Cerebral Spinal Fluid (CSF) in epidural needle CSF in catheter or positive aspiration test spinal anaesthesia after test dose t applicable [0-120] hr : HH:MM [0-23] hrs [0-59] min 29.1 if other specify: auditory symptoms diplopia... dizziness other visual symptoms tinnitus other 30.1 if specify treatment: (multiple alternatives allowed) Paracetamol NSAID Caffeine Opioids luids edrest Page 2 of 10

3 Was the patient already sent home when symptoms first presented? If, when (date)? Can the mother breastfeed her child despite post-dural puncture headache? 33 What was the numeric rating score (NRS) pain intensity lying down at PDPH diagsis? 34 What was the numeric rating score (NRS) pain intensity when sitting up at PDPH diagsis? 35 Where was the location of the headache (multiple answers possible) 36 Was conservative management initiated after confirmed diagsis by Anaesthesiologist? 37 Did other new symptoms arise after confirmed diagsis of PDPH? (multiple alternatives allowed) temporal occipital frontal neck shoulder other 36.1 If, why conservative management was already initiated before diagsis by an anaesthesiologist severe symptoms requiring prompt relief other reasons If other specify: If, what was the conservative management after diagsis? (> 1 choice acceptable) Paracetamol NSAID Caffeine opioids Fluids Bed rest Nausea/vomiting Diplopia Other Visual symptoms Tinnitus Others uditory symptoms 38 Maximum NRS pain intensity (lying down) after confirmed diagsis and during 0-24 h 39 Maximum NRS pain intensity (standing) after confirmed diagsis of PDPH and during 0-24 h? 40 After initial conservativemanagement, how did management proceed? NB. If after a variable period of continuing conservative management (0-5 days), it was then decided to perform an EBP, please fill both sections 2A and 2B Not performed Continuing conservative management (proceed to fill section 2A) Epidural blood patch (proceed to fill section 2B) No further treatment was performed, patient is discharged (proceed to Follow-up step 6) 40.1 if discharged, provide date: Page 3 of 10

4 Step 2. Management of PDPH after diagsis and initial management Step 2A. Continued conservative management 1 Did the patient refuse to have an EBP despite physician recommendation? 2 What was the maximum NRS pain intensity (lying down) during hospital stay? 3 What was the maximum NRS pain intensity (standing) during hospital stay? 4 When was the patient discharged home after PDPH diagsis? 5 What was the NRS pain intensity (lying down) at discharge? 6 What was the NRS pain intensity (standing) at discharge? 7 Did the patient contact the hospital or was readmitted after initial discharge due to PDPH? Not performed (end of questionnaire, go to follow up step 6) but EBP was performed (go to follow up step 6), patient received an EBP ( go to step 2B) Step 2B. Management of Epidural Blood Patch (EBP) 1 What is the experience of the anaesthesiologist in performing EBP? 2 When was EBP inserted? Exact date: 3 Time of day: < 1 EBP 1-5 EBP 5-10 EBP : HH:MM [0-23] hrs [0-59] min 4 What was the position of the patient when the EBP was performed? Sitting ying down 5 What was the worst NRS pain intensity (lying down) in previous 6-12 h before inserting EBP? 6 What was the worst NRS pain intensity (standing) in previous 6-12 h before inserting EBP? 7 Level of insertion of epidural needle for epidural blood patch 8 Was there any technical difficulty in performing the EBP (obesity, scoliosis, previous scar)? 9 What was the volume of blood injected? (ml) [0-40] 10 When was the patient first mobilised after EBP? hr [0-24] (hours after EBP) 11 What was the NRS pain intensity (lying down) Not performed L1-2 L2-3 L If specify:... after inserting EBP? (before mobilization) 12 What was the NRS pain intensity (standing/ during first mobilization) after inserting EBP? 13 What was the NRS pain intensity (lying down) 4 h after inserting EBP? Page 4 of 10

5 14 What was the NRS pain intensity (standing/walking) 4 h after inserting EBP? 15 What was the NRS pain intensity (lying down) 24 h after inserting EBP? 16 What was the NRS pain intensity (standing) 24 h after inserting EBP? (primary endpoint) NB. If the patient is in hospital, ask a direct question. If discharged, please call and enquire 17 Did the patient have other symptoms after inserting EBP? Not performed 17.1 If, specify symptoms (multiple alternatives possible) significant backache auditory symptoms visual symptoms bradycardia 18 Did the patient experience persistent or recurrent PDPH after first EBP and before discharge? 18.1 If, when was the patient discharged home after PDPH diagsis? (continue to step 3) (continue to next item 18.1) 18.2 Was the patient re-admitted after discharge due to persistent or recurrent PDPH after first EBP? (end of this questionnaire, please proceed to step 6 Followup) (continue with step 3 below) Page 5 of 10

6 Step 3: RE-ADMISSION OR PERSISTENT post-dural puncture headache (PDPH) 24 h after EBP 1 If PDPH continues, what was the NRS pain intensity at 48 after EBP? (lying down) 2 If PDPH continues, what was the NRS pain intensity at 48 h after EBP? (standing) 3 Were there other symptoms in addition to PDPH? (multiple alternatives allowed) 4 Following re-admission or within 24 h after EBP, how was the patient managed? (tick all applicable) 5 Were further diagstic measures taken for confirmation of persistent PDPH? 3.1 If, specify: auditory symptom others significant backache visual symptoms Conservative management re-started EBP re-inserted Others specify: If, proceed to item If, specify:... 6 Describe what the diagstic measures revealed extrathecal CSF, "sagging" of I/C structures, meningeal enhancement) 7 Was a new EBP inserted? 8 What is the experience of the anaesthesiologist in performing this EBP? When was the second EBP inserted? 9 Exact date 10 time of day 11 Level of insertion of epidural needle for epidural blood patch 12 What was the worst NRS pain intensity (lying down) before second EBP (0-12 h)? 6.1 If other, specify:... If, please complete questions 23 and 24 and proceed to follow-up (step 6) If, please answer questions 8 to 24 < 1 EBP 1-5 EBP 5-10 EBP - - [>=01-Jan-2016 : HH:MM [0-23] hrs [0-59] min L1-2 L2-3 L Page 6 of 10

7 13 What was the worst NRS pain intensity (standing) before second EBP (0-12 h)? 14 Was there any technical difficulty in performing second EBP? (obesity, scoliosis, previous scar) 15 What was the volume of blood injected? (ml) [0-40 ] 16 When was the patient first mobilised after second EBP? [0-99] hr (hours after second EBP) 17 What was the NRS pain intensity (lying down) 4 h after inserting second EBP? 18 What was the NRS pain intensity (standing/walking) 4 h after inserting second EBP? Not performed 19 What was the NRS pain intensity (lying down) 24 h after inserting second EBP? 20 What was the NRS pain intensity (standing) 24 h after inserting second EBP NB. If the patient is in hospital, ask a direct question. If Not performed discharged, please call and enquire? 21 Did the patient have other symptoms after inserting second EBP? 21.1 If, specify symptoms (multiple alternatives possible) significant backache auditory symptoms visual symptoms neurological sequelae 22 Did the patient experience persistent or recurrent PDPH after second EBP and before discharge 23 When was the patient discharged home? 24 Was the patient re-admitted after discharge due to persistent or recurrent PDPH after second EBP? (continue to step 4) (continue to below - item 23) (end of questionnaire, go to step 6 follow-up) (continue below step 4) Page 7 of 10

8 Step 4: PERSISTENT or RECURRENT Post-Dural Puncture Headache (PDPH), DESPITE SECOND EBP 1 Were further diagstic measures taken for confirmation of PDPH? 2 Describe what the diagstic measures revealed intracranial thrombosis 1.1 If, specify: If Others, specify: CSF, "sagging" of I/C structures, meningeal enhancement) 2.1 If other, specify:... 3 Following diagsis or within 24 h after second EBP, how was the patient managed? 4 What is the experience of the anaesthesiologist in performing 5 6 this EBP? When EBP was inserted? Exact date and Time nearest hour Wait and watch => continue to question 15 Conservative management restarted => continue to question 15 EBP => please answer questions below < 1 EBP 1-5 EBP 5-10 EBP : HH:MM [0-23] hrs [0-59] min 7 What was the NRS pain intensity (standing) before inserting third EBP? (previous 6-12 h before third EBP) 8 Was there any technical difficulty in performing the third EBP? 9 What was the volume of blood injected? (ml) [0-40] 10 When was the patient first mobilised after third EBP? [0-99] (hours after third EBP) 11 What was the NRS pain intensity (standing) after inserting third EBP? 12 What was the NRS pain intensity (standing) 24 h after inserting third EBP? 13 Did the patient have other symptoms after inserting third EBP? 13.1 if, specify symptoms (multiple alternatives allowed) significant backache auditory symptoms visual symptoms 14 Did the patient experience persistent or recurrent PDPH after third EBP and before discharge sequelae (continue below step 5) (continue to 15 below) 15 When was the patient discharged home? Page 8 of 10

9 16 Was the patient re-admitted after discharge due to persistent or recurrent PDPH after third EBP? => end of questionnaire, go to step 6 follow-up => If (continue below step 5); Step 5: PERSISTENT or RECURRENT Post-Dural Puncture Headache (PDPH), DESPITE THIRD EBP 1 If re-admitted, what was the NRS pain intensity (standing) on re-admission? 2 Were there other symptoms in addition to PDPH? (multiple alternatives allowed) significant backache auditory symptoms visual symptoms 3 Was conservative management started on Re-admission? 4 Were further diagstic measures taken for confirmation of PDPH? 5 Describe what the diagstic measures revealed 4.1 Others specify intracranial bleeding extrathecal CSF, "sagging" of I/C structures, meningeal enhancement) 5.1 If other, specify:... 6 When was the patient discharged home? Page 9 of 10

10 Step 6: Follow-up 1 What was the NRS pain intensity (lying down) 7 days after confirmation of PDPH (+/- 1 day) What was the NRS pain intensity (standing/walking) 7 days after confirmation of PDPH (+/- 1 day) Was a follow-up telephone call made 3 months after confirmation of PDPH? (+/- 2 weeks) Date of Month 3 follow-up telephone call What was the post-dural puncture headache (PDPH) pain intensity (NRS on lying) 3 months after PDPH? What was the PDPH pain intensity (NRS on standing) 3 months after PDPH? Were there other symptoms in addition to PDPH? Not performed No. If t, END OF QUESTIONNAIRE. THANK YOU Yes. If, please continue below (If specify below) 7.1 Nausea/vomiting? What was the intensity? [0-10] 7.2 Significant backache? What was the intensity? [0-10] 7.3 Auditory symptom? What was the intensity? [0-10] 7.4 Visual symptoms? What was the intensity? [0-10] 7.5 Neck stiffness? What was the intensity? [0-10] Others? Was the patient taking analgesics regularly due to headache or backache at 3 months? Were there any complications (with or without EBP)? Was the patient re-admitted after discharge and before 3 months for possible PDPH-related sequelae? If other, specify: What was the intensity? [0-10] 8.1 If, specify: paracetamol NSAID/COX-2 others 10.1 If, describe: If, reason for readmission: If, date of readmission: - - [>=01-Jan-2016] THANK YOU FOR PARTICIPATING Page 10 of 10

EPiMAP Obstetrics European Practices in the Management of Accidental Dural Puncture in Obstetrics

Appendix 3: Pre-study Questionnaire EPiMAP Obstetrics European Practices in the Management of Accidental Dural Puncture in Obstetrics All questions in this questionnaire relate to the situation in 2014