Are you healthy and looking to help advance medical science?

You may be eligible to participate in a postdural puncture headache clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a postdural puncture headache clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Postdural Puncture Headache Clinical Trial in New Brunswick NJ

NCT03112720 | Phase 3 | Interventional

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a postdural puncture headache clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a postdural puncture headache clinical study, and could be compensated for your time.

Recruiting

Male & Female

13 - 92

Years old

This study is looking to recruit 500 Participants

The purpose of this study is to compare a pain block in the midface, versus the traditional, more invasive, therapeutic epidural patch for the treatment of headaches

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Details for the study

Brief Title

Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

Official Title

A Comparison of the Efficacy of Sphenopalatine Ganglion (SPG) Block With 5% Lidocaine Versus Epidural Blood Patch (EBP) for the Treatment of Post-Dural Puncture Headache (PDPH)

Brief Summary

The purpose of this study is to compare a pain block in the midface, versus the traditional,<br /> more invasive, therapeutic epidural patch for the treatment of headaches

Detailed Description

The sphenopalatine nerve block has been used to treat headaches. Patients have headaches
after epidural access from post dural puncture. We need to know if sphenopalatine nerve block
will help the patient with the headache.

Treatments and/or Procedures

Epidural blood patch

A device: 17 gauge Tuohy needle will be placed to the epidural space using the loss of resistance technique. Once positioned a sterile stylet will be replaced within the needle to maintain the sterility of the epidural space. A tourniquet may be used to identify a peripheral venous site, which will be sterilely prepped with betadine x3 and then chloraprep. Venipuncture will be performed with a device: 20gauge or larger needle. 20mL of blood will be aspirated in a sterile system into an appropriately sized syringe. After sterile transfer, this autologous blood will be slowly injected into the epidural space.

Sphenopalatine ganglion block

The drug: 5% lidocaine ointment, a local anesthetic, will be applied to the end of a device: long channeled cotton tipped applicator inserted into both nares and placed over the mucosa in the area of posterior aspect of the middle ethmoid, toward the presumed anatomic location of the sphenopalatine ganglion, evidenced by a slight resistance at the appropriate depth. 5mL of drug: 1% lidocaine solution will then be injected into the hollow shaft of the device: applicator and allowed to topically anesthetize the ganglion by gravity flow for 30 minutes.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Pain Questionnaire at 24 hours following either therapy.

Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined within the description of outcome 1 above) by way of telephone based assessment by pain questionnaire at 24 hours following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).

At 24 hours following either therapy.

Primary

Pain Questionnaire prior to initiation of either therapy

Outcome measure will entail recording patient self-reported pain scores to quantify the level of headache pain using the Visual analog scale, meaning 0 - No pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-10 - Severe Pain, by way of in person assessment by pain questionnaire just prior to initiation of either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).

Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).

Primary

Pain Questionnaire at 30 minutes following either therapy.

Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined within the description of outcome 1 above) by way of in person assessment by pain questionnaire at 30 minutes following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).

At 30 minutes following either therapy.

Primary

Pain Questionnaire at 60 minutes following either therapy.

Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined within the description of outcome 1 above) by way of in person assessment by pain questionnaire at 60 minutes following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).

At 60 minutes following either therapy.

Primary

Pain Questionnaire at 48 hours following either therapy.

Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined within the description of outcome 1 above) by way of telephone based assessment by pain questionnaire at 48 hours following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).

At 48 hours following either therapy.

Study Criteria

Inclusion Criteria:

  -  Males and females ages 13-92

  -  Subjects have medical diagnosis of PDPH and require treatment

  -  Subjects who signed consent/assent

Exclusion Criteria:

  -  <13 years of age

  -  Pregnancy

  -  Subjects with heart failure

  -  Subjects already being treated with lidocaine patch or other vehicle for chronic pain

  -  Non-english speaking subjects

  -  Subjects with platelets <100,000

  -  Subjects that are septic

  -  Subjects with an allergy to lidocaine

  -  Subjects with known nasal polyps

  -  Subjects with recent neurological event

  -  Subjects on anticoagulant therapy

  -  Subjects that received prior therapy with SPG block or EBP