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RCT of SPG Blocks for Post-dural Headache

NCT03560349 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-12-13

No results posted yet for this study

Summary

The purpose of the study is to assess the effectiveness of the SPG block with lidocaine vs. SPG block with placebo on preventing the need for EBP in women who develop PDPH after accidental dural puncture during placement of LEA for labor.

Conditions

  • Post-Dural Puncture Headache

Interventions

DRUG

Lidocaine HCl Gel 2%

Patients will be prescribed a regimen of 1 g acetaminophen q 8hrs alternating with 600 mg ibuprofen q 6 hours. In addition they will be instructed to continue oral fluid hydration and minimal activity for 24 hours. At 2-hours following the SPG blockade an EBP will be offered to patients. Patient will also be informed that they can request an EBP at any time. The SPG blockade will be performed twice daily in the hospital and twice daily at home, by the patient. The patient will also be informed, if that at anytime, they would like an EBP, it can be provided. While the study is being conducted, patients will not be offered a SPG block unless enrolled in the study.

DRUG

placebo gel

Patients will be prescribed a regimen of 1 g acetaminophen q 8hrs alternating with 600 mg ibuprofen q 6 hours. In addition they will be instructed to continue oral fluid hydration and minimal activity for 24 hours. At 2-hours following the SPG blockade an EBP will be offered to patients. Patient will also be informed that they can request an EBP at any time. The SPG blockade will be performed twice daily in the hospital and twice daily at home, by the patient. The patient will also be informed, if that at anytime, they would like an EBP, it can be provided. While the study is being conducted, patients will not be offered a SPG block unless enrolled in the study.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-01-01
Completion
2019-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03560349 on ClinicalTrials.gov