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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine | Experimental | Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. |
|
| Saline | Placebo Comparator | Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Report Post Dural Puncture Headaches | Participants who report post dural puncture headaches from delivery to postpartum day 5 | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Time of unintentional dural puncture to postpartum day 5 |
| Treatment Method for Headache |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feyce Peralta, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20682567 | Background | 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. | |
| 3605700 | Background | 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. |
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68 were consented to participate in the study . 2 withdrew and 3 were excluded for non-functional catheter.
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| ID | Title | Description |
|---|---|---|
| FG000 | Morphine | Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: 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. |
| FG001 | Saline | Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Morphine | Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants Who Report Post Dural Puncture Headaches | Participants who report post dural puncture headaches from delivery to postpartum day 5 | Posted | Count of Participants | Participants | 5 days |
|
5 days after delivery of baby.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Morphine | Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New onset nausea | Gastrointestinal disorders | Systematic Assessment |
The results of our study should only be interpreted in the context of its limitations. Our sample size is small and we stopped the study prior to meeting our original estimated sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Feyce Peralta, MD | Northwestern University | 312-472-3585 | f-peralta@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2018 | Dec 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| D065634 | Cerebrospinal Fluid Leak |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
|
| Saline | Drug | 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. |
|
|
Treatment method completed for unintentional dural puncture headache. |
| 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. | 5 days |
| Repeat Epidural Blood Patch | Repeated epidural blood patch for headache pain after unintentional dural puncture. | After first epidural blood patch to 5 days after delivery |
| Presenting Day of Headache | Presenting day of headache after unintentional dural puncture | 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 | 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. | 5 days |
| Intrathecal Catheter Dwell Time | Intrathecal catheter dwell time(time from insertion to time of removal in minutes). | Insertion time to removal in minutes |
| Intrathecal Infusion Volume | Intrathecal infusion volume in milliliters | Time of insertion of catheter to time catheter removed |
| Mode of Delivery | Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery) | up to 10 hours after intrathecal catheter placed |
| 12734154 | Background | 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. |
| 8826568 | Background | 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. |
| 19945855 | Background | 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. |
| 15814755 | 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. |
| 6118577 | Background | 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. |
| 12076420 | Background | 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. |
| 20613476 | Background | 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. |
| 10638928 | Background | 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. |
| 14634940 | Background | 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. |
| 11464346 | Background | 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. |
| 7839783 | Background | 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. |
| 15564951 | Background | 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. |
| 2278354 | Background | 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. |
| 18547293 | Background | 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. |
| 15321606 | Background | 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. |
| 15145989 | Background | 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. |
| BG001 | Saline | Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ethnicity | Count of Participants | Participants |
|
| Body Mass Index (kg/m^2) | Body mass index (BMI) is derived from the (weight) and height of the subject. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m^2. | Median | Inter-Quartile Range | kg/m^2 |
|
| Nulliparous | Number of participants who presented as nulliparous. | Count of Participants | Participants |
|
| Gestational age (weeks) | Median | Full Range | Weeks |
|
| Loss of resistance method | Loss of resistance method of catheter placement (either air or saline) used by the operator. | Count of Participants | Participants |
|
| Intrathecal catheter depth (cm) | The final depth of the placement of the catheter in centimeters. | Median | Inter-Quartile Range | Centimeters (cm) |
|
| Unable to aspirate prior to administering study drug (n) | The number of subjects whose intrathecal catheter were unable to be aspirated prior to study drug administration. | Count of Participants | Participants |
|
| OG001 | Saline | Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. 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. |
|
|
|
| Secondary | 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. | 21 in the morphine group and 27 in the saline group experienced headaches. | Posted | Median | Inter-Quartile Range | score on a scale | Time of unintentional dural puncture to postpartum day 5 |
|
|
|
|
| Secondary | Treatment Method for Headache | Treatment method completed for unintentional dural puncture headache. | 21 in the morphine group and 27 in the saline group experienced unintentional post dural puncture headaches. | Posted | Count of Participants | Participants | Unintentional dural puncture - Postpartum day 5 |
|
|
|
|
| Secondary | 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. | 21 in the morphine group and 27 in the saline group experienced unintentional dural puncture headaches. | Posted | Count of Participants | Participants | 5 days |
|
|
|
|
| Secondary | Repeat Epidural Blood Patch | Repeated epidural blood patch for headache pain after unintentional dural puncture. | Posted | Count of Participants | Participants | After first epidural blood patch to 5 days after delivery |
|
|
|
|
| Secondary | Presenting Day of Headache | Presenting day of headache after unintentional dural puncture | 21 in the morphine group and 27 in the saline group experienced headache after unintentional dural puncture. | Posted | Count of Participants | Participants | Dural puncture to 5 days after delivery |
|
|
|
|
| Secondary | 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 | 21 in the morphine group and 27 in the saline group experienced headache after unintentional dural puncture. | Posted | Count of Participants | Participants | 5 days |
|
|
|
|
| Secondary | 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. | 21 in the morphine group and 27 in the saline group experienced unintentional post dural puncture headache. | Posted | Median | Full Range | Score on a scale (0=no pain to 10 worst) | 5 days |
|
|
|
|
| Secondary | Intrathecal Catheter Dwell Time | Intrathecal catheter dwell time(time from insertion to time of removal in minutes). | Posted | Median | Inter-Quartile Range | Insertion to removal time in minutes | Insertion time to removal in minutes |
|
|
|
|
| Secondary | Intrathecal Infusion Volume | Intrathecal infusion volume in milliliters | Posted | Median | Inter-Quartile Range | Milliters | Time of insertion of catheter to time catheter removed |
|
|
|
|
| Secondary | Mode of Delivery | Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery) | Posted | Count of Participants | Participants | up to 10 hours after intrathecal catheter placed |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Saline | Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. 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. | 0 | 34 | 0 | 34 | 0 | 34 |
| New onset vomiting | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Hydration |
|
| Auditory |
|
| Day 3 |
|
| Day 4 |
|
| 3 day |
|
| 4 day |
|
| 5 day |
|