Headache
Conditions
Brief summary
The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period.
Detailed description
The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period. A known dural puncture is defined as free flow of cerebral spinal fluid (CSF) during neuraxial placement. An unknown dural puncture is defined as neuraxial placement where free flow of CSF is not appreciated, however the patient is diagnosed with a post-dural puncture headache as defined by the International Classification of Headache Disorders.
Interventions
DRUGSphenopalatine ganglion Block
PROCEDUREEpidural blood patch
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or age or greater 2. Postpartum obstetric parturient who was previously admitted to UCH. 3. Diagnosis of post-dural puncture headache based on the International Classification of Headache Disorders: 1. Dural puncture has been performed 2. Headache has developed within 5 days of the dural puncture 3. Not better accounted for by another ICHD-3 diagnosis. 4. Occurring immediately or within seconds of assuming an upright position and resolving quickly (within 1 minute) after lying horizontally.
Exclusion criteria
1. Refusal to participate in the study 2. Placement of an EBP within the past 5 days 3. Allergy and/or intolerance to any the study materials 4. Contraindications to an EBP 5. Plan for therapeutic anticoagulation post-partum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in The Numerical Rating Scale Pain Score | Baseline and 48 hours | The Numerical Rating Scale (NRS) is commonly used to evaluate pain level in patients. It is presented as a numerical scale of 11 options, numbered 0-10, where the patient's pain intensity is represented by a number between the extremes of 0 = no pain at all to 10 = worst pain imaginable in numerical fashion. Its simplicity, reliability, and validity have made the NRS a useful tool for describing pain severity or intensity. The Investigators will consider a difference of 20% as a clinically significant change in pain score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sphenopalatine Ganglion Block Sphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes.
Sphenopalatine ganglion Block | 3 |
| Epidural Blood Patch Epidural Blood Patch: The patient is positioned in the sitting or lateral positon. Using aseptic technique, 20mL of autologous blood is drawn by a trained practitioner. The epidural placement is performed by a trained practitioner using aseptic technique and the vertebral space accessed is at or immediately below the original neuraxial placement. After entrance into the epidural space is confirmed with loss of resistance technique to either air or saline, 15-20 milliliters of sterile autologous venous blood is injected. After the procedure the patient rests supine for at least 1 hour. Patients are instructed to avoid heavy lifting, abdominal straining, or coughing for at least 48 hours.
Epidural blood patch | 1 |
| Total | 4 |
Baseline characteristics
| Characteristic | Sphenopalatine Ganglion Block | Epidural Blood Patch | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Continuous | 29 Years STANDARD_DEVIATION 4.36 | 30 Years STANDARD_DEVIATION 0 | 29.25 Years STANDARD_DEVIATION 3.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 3 participants | 1 participants | 4 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
Change in The Numerical Rating Scale Pain Score
The Numerical Rating Scale (NRS) is commonly used to evaluate pain level in patients. It is presented as a numerical scale of 11 options, numbered 0-10, where the patient's pain intensity is represented by a number between the extremes of 0 = no pain at all to 10 = worst pain imaginable in numerical fashion. Its simplicity, reliability, and validity have made the NRS a useful tool for describing pain severity or intensity. The Investigators will consider a difference of 20% as a clinically significant change in pain score.
Time frame: Baseline and 48 hours
Population: Some subjects refused to give a 48 hour score.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sphenopalatine Ganglion Block Baseline Score | Change in The Numerical Rating Scale Pain Score | Subject 001 | 8 score on a scale |
| Sphenopalatine Ganglion Block Baseline Score | Change in The Numerical Rating Scale Pain Score | Subject 003 | 4 score on a scale |
| Sphenopalatine Ganglion Block Baseline Score | Change in The Numerical Rating Scale Pain Score | Subject 004 | 10 score on a scale |
| Sphenopalatine Ganglion Block 48 Hours Score | Change in The Numerical Rating Scale Pain Score | Subject 001 | 0 score on a scale |
| Sphenopalatine Ganglion Block 48 Hours Score | Change in The Numerical Rating Scale Pain Score | Subject 004 | 5 score on a scale |
| Epidural Blood Patch Baseline Score | Change in The Numerical Rating Scale Pain Score | Subject 002 | 8 score on a scale |