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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02181205
Other study ID # 14-024
Secondary ID
Status Withdrawn
Phase N/A
First received July 1, 2014
Last updated November 6, 2017
Start date November 2014
Est. completion date December 31, 2016

Study information

Verified date February 2017
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists assigned class I-III

- age >/= 18 years

- experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated >3/10 pain score

Exclusion Criteria:

- allergy to study medications <18 years of age pain score on presentation </=3/10 for headache

Study Design


Intervention

Drug:
bupivacaine

placebo


Locations

Country Name City State
United States Novant Health Forsyth Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary verbal pain score a reduction in headache verbal pain score by 3 1 hour
Secondary epidural blood patch evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache 7 days
Secondary patient satisfaction patient satisfaction with headache pain relief at 1 hour post treatment 1 hour
Secondary pain score verbal pain score 30 minutes post study treatment 30 minutes
Secondary pain score verbal pain score 7 days post study treatment 7 days
See also
  Status Clinical Trial Phase
Terminated NCT03112720 - Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache Phase 3
Suspended NCT02473276 - 2 Dose Neuraxial Morphine for Prevention of PDPH Phase 4
Completed NCT03652714 - The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache Phase 3
Completed NCT02859233 - Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache N/A
Completed NCT01977898 - Incidence of Headache Following an Unintentional Dural Puncture N/A
Completed NCT06394024 - Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment
Withdrawn NCT03966547 - Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714 N/A
Completed NCT06380764 - Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache N/A
Terminated NCT02365909 - Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH) Early Phase 1
Completed NCT04910477 - Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache Phase 3
Completed NCT05969119 - Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache Phase 4
Completed NCT02150304 - Aminophylline Prophylaxis For Postdural Puncture Headache N/A
Not yet recruiting NCT04709029 - Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache N/A
Withdrawn NCT02517931 - Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department N/A
Recruiting NCT06271486 - Pregabalin in Treatment of Postdural Puncture Headache Phase 3
Completed NCT00465166 - Lumbar Spine Ultrasound of Patients With Previous Accidental Dural Puncture During Labour Epidural N/A
Not yet recruiting NCT05212194 - The Relationship Between Post Dural Puncture Headache and Joint Laxity N/A
Completed NCT05777694 - Postdural Punction Headache After Ceserian Section N/A
Withdrawn NCT04515901 - Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches N/A
Completed NCT04892290 - Sphenopalatine Ganglion Block for Postdural Puncture Headache