A Phase 3 interventional study of Lidocaine-Prilocaine Cream and Placebo Cream in Pain, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-16.
Sponsored by Stanford University · Phase 3, Interventional, and Treatment
The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes prior to the administration of a paracervical block could decrease pain associated with its administration and pain with abortion overall.
This is a superiority, double-blind randomized controlled trail of women ages 18 and older presenting for first-trimester surgical abortion. The lidocaine-prilocaine cream will be used in the experimental group in conjunction with a paracervical block, whereas plain lubricating gel will be used in conjunction with a paracervical block for the placebo, control group.
Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the lidocaine-prilocaine cream vaginally using a syringe
Drug: Lidocaine-Prilocaine Cream · Drug: 1% Lidocaine Paracervical Block
5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe
Drug: Placebo Cream · Drug: 1% Lidocaine Paracervical Block
10ml of vaginally self-administered cream composed of an eutectic mixture of 2.5% lidocaine, 2.5% prilocaine
Also known as: EMLA
10ml of vaginally self-administered placebo cream
Paracervical block of 10ml of 1% lidocaine
Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation
Time frame: Intraoperative; Immediately following cervical dilation
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Stanford University