For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
Stanford Gynecology Clinic
Palo Alto, California, United States
(IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion
Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Time frame: 0-3 minutes after procedure completed
Anticipated Pain as Measured by a Visual Analog Scale
Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Time frame: 30 Minutes prior to procedure
Baseline Pain as Measured by a Visual Analog Scale
Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Time frame: Immediately prior to procedure; upon arrival to procedure room
Pain After Speculum Placement as Measured by a Visual Analog Scale
Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Time frame: Intraoperative
Pain After Tenaculum Placement as Measured by a Visual Analog Scale
Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Time frame: Intraoperative
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