Incidence of Headache Following an Unintentional Dural Puncture

NCT01977898 | Completed Results

• 1 other identifier: STU00043549
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Participants Who Report Post Dural Puncture Headaches

  Participants who report post dural puncture headaches from delivery to postpartum day 5

  5 days

Secondary Outcomes (10)

• Severity of Post Dural Puncture Headache

  Time of unintentional dural puncture to postpartum day 5

• Treatment Method for Headache

  Unintentional dural puncture - Postpartum day 5

• Number of Participants With Cranial Nerve Symptoms

  5 days

• Repeat Epidural Blood Patch

  After first epidural blood patch to 5 days after delivery

• Presenting Day of Headache

  Dural puncture to 5 days after delivery

Study Arms (2)

Morphine

EXPERIMENTAL

Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.

Drug: Morphine

Saline

PLACEBO COMPARATOR

Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.

Drug: Saline

Interventions

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.

Also known as: Duramorph

Morphine

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.

Also known as: Normal Saline

Saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Postpartum patients following vaginal delivery
• Unintentional dural puncture
• Functioning intrathecal catheter
• Patients must be 18 years of age or older
• English speaking.

You may not qualify if:

• History of previous PDPH
• Body mass index BMI \> 40 kg/m2
• History of obstructive sleep apnea (OSA)
• Morphine allergy
• Patients who receive Cesarean delivery

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (18)

• 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.

  PMID: 20682567 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.

  PMID: 3605700 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.

  PMID: 12734154 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.

  PMID: 8826568 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.

  PMID: 19945855 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

• 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.

  PMID: 6118577 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.

  PMID: 12076420 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.

  PMID: 20613476 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.

  PMID: 10638928 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.

  PMID: 14634940 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.

  PMID: 11464346 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.

  PMID: 7839783 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.

  PMID: 15564951 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.

  PMID: 2278354 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.

  PMID: 18547293 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.

  PMID: 15321606 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.

  PMID: 15145989 BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache; Cerebrospinal Fluid Leak; Headache

Interventions

Morphine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Pain

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

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.

Results Point of Contact

• Title: Feyce Peralta, MD
• Organization: Northwestern University

f-peralta@northwestern.edu

312-472-3585

Study Officials

• Feyce Peralta, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Anesthesiology

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: November 1, 2011
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: November 17, 2021
• Results First Posted: April 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)