Chronic Headache and Chronic Backache Following Unintentional Dural Puncture at Delivery Room.

NCT03908424 | Completed DMC

• 1 other identifier: 0335-18-SZMC
• Study Type: observational
• Target: 389
• Locations: 1 country
• Sites: 1

Brief Summary

he study is a telephone questionnaire. The study will include 400 women, 100 in each group. OBJECTIVE: To investigate the prevalence of chronic and chronic back pain following PDPH accidental dural puncture during epidyral analgesia for delivery.

1. 1.Parturients who gave birth to a normal birth and did not receive epidural anesthesia.
2. 2.Parturients who gave birth to a normal birth with epidural anesthesia without an unintentional dural puncture.
3. 3.Parturients who gave birth to a normal birth with epidural anesthesia and had an unintentional dural puncture, these women were treated conservatively.
4. 4.Parturients who had a normal birth with epidural anesthesia and had an unintentional dural puncture and were treated with a blood patch following PDPH.

Conditions

Parturient Who Underwent Epidural Anesthesia During Which an Unintentional Dural Punctur Occurred; Parturient Who Develop a Postdural Puncture Headache; Parturient Who Gave Informed Consent to Participation in the Study

Keywords

PDPH - Post Dural Puncture Headache; chronic headache; chronic backache

Outcome Measures

Primary Outcomes (2)

• Chronic Headache

  Chronic headache development after PDPH, comparison between different groups. The diagnosis of chronic headache will be done using a questionnaire (attached as an appendix) including the Chronic Pain Grade Questionnaire (Smith et al). The main questions in the questionnaire are the incidence of headache, the severity of the headache, the duration of the problem. Disability Index is also determined by the questions about limiting pain in daily activities.

  At least six months after birth.

• chronic Backache

  Chronic backache development after PDPH, comparison between different groups. The diagnosis of chronic back pain will be done using a questionnaire (attached as an appendix) including the Low Back Pain Rating Scale (Manniche et al.). The main questions in the questionnaire are the incidence of back pain, severity of back pain, duration of the problem. Disability Index is also determined by the questions about limiting pain in daily activities.

  At least six months after birth.

Study Arms (4)

CONTROL

Parturients who gave birth to a normal birth and did not receive epidural anesthesia.

Normal Epidural

Parturients who gave birth to a normal birth with epidural anesthesia without an unintentional dural puncture.

PDPH conservative treatment

Parturients who gave birth to a normal birth with epidural anesthesia and had an unintentional dural puncture, these women were treated conservatively.

PDPH treated with Blood Patch

. Parturients who had a normal birth with epidural anesthesia and had an unintentional dural puncture and were treated with a blood patch following PDPH.

Other: Epidural Blood patch.

Interventions

Epidural Blood patch. OTHER

An epidural blood patch is a surgical procedure that uses autologous blood in order to close one or many holes in the dura mater of the spinal cord, usually as a result of a previous lumbar puncture. A small amount of the patient's blood is injected into the epidural space near the site of the original puncture; the resulting blood clot then "patches" the meningeal leak. An epidural needle is inserted into the epidural space at the site of the cerebrospinal fluid leak and blood is injected. The clotting factors of the blood close the hole in the dura.

PDPH treated with Blood Patch

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women who gave birth at Shaare Zedek Medical Center are a tertiary hospital with more than 16,000 births a year. Fifty-five percent of women give birth with epidural anesthesia.

You may qualify if:

• Parturient who underwent epidural anesthesia during which an unintentional dural punctur occurred.
• Parturient who develop a postdural puncture headache.
• Parturient who gave informed consent to participation in the study.

You may not qualify if:

• Parturient without a clear dural hole during operation.
• Parturient who have chronic headaches or migraines.
• Parturient who have chronic back pain.
• Parturient who did not give informed consent.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Meedical Center

Jerusalem, Israel

Location

Related Publications (5)

• Loubert C, Hinova A, Fernando R. Update on modern neuraxial analgesia in labour: a review of the literature of the last 5 years. Anaesthesia. 2011 Mar;66(3):191-212. doi: 10.1111/j.1365-2044.2010.06616.x.

  PMID: 21320088 RESULT

• Paech M, Banks S, Gurrin L. An audit of accidental dural puncture during epidural insertion of a Tuohy needle in obstetric patients. Int J Obstet Anesth. 2001 Jul;10(3):162-7. doi: 10.1054/ijoa.2000.0825.

  PMID: 15321604 RESULT

• Berger CW, Crosby ET, Grodecki W. North American survey of the management of dural puncture occurring during labour epidural analgesia. Can J Anaesth. 1998 Feb;45(2):110-4. doi: 10.1007/BF03013247.

  PMID: 9512843 RESULT

• MacArthur C, Lewis M, Knox EG. Accidental dural puncture in obstetric patients and long term symptoms. BMJ. 1993 Apr 3;306(6882):883-5. doi: 10.1136/bmj.306.6882.883.

  PMID: 8490410 RESULT

• Smith BH, Penny KI, Purves AM, Munro C, Wilson B, Grimshaw J, Chambers WA, Smith WC. The Chronic Pain Grade questionnaire: validation and reliability in postal research. Pain. 1997 Jun;71(2):141-7. doi: 10.1016/s0304-3959(97)03347-2.

  PMID: 9211475 RESULT

MeSH Terms

Conditions

Post-Dural Puncture Headache; Headache Disorders

Interventions

Blood Patch, Epidural

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Injections, Epidural; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Obstetric and Ambulatory Anesthesia

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 9, 2019
• Study Start: May 1, 2019
• Primary Completion: August 11, 2020
• Study Completion: August 11, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

IL (1)