Treatment of Post-dural Puncture Headache in Postpartum Patients: Sphenopalatine Ganglion Block to Epidural Blood Patch.
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|ClinicalTrials.gov Identifier: NCT02962427|
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : December 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Headache||Drug: Sphenopalatine ganglion Block Procedure: Epidural blood patch||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Post-dural Puncture Headache in Postpartum Parturients: Comparing Sphenopalatine Ganglion Block to Epidural Blood Patch.|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: 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 The swabs are withdrawn after 30 minutes.
Drug: Sphenopalatine ganglion Block
Other Name: SGB
Active Comparator: 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.
Procedure: Epidural blood patch
Other Name: EBP
- Change in The Numerical Rating Scale Pain Score [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962427
|Contact: Colleen K Dingmann, R.N., Ph.D.||email@example.com|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Colleen Dingmann, R.N., Ph.D. 303-724-7494 firstname.lastname@example.org|
|Principal Investigator:||Cristina Wood, M.D.||University of Colorado Anschutz Medical Campus - School of Medicine, Dept. of Anesthheisology|