The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.
Lidocaine-prilocaine (EMLA 5%) cream has been shown to be effective in reducing pain during minor gynecologic procedures. The primary objective of this trial is to determine if the use of 5% EMLA cream at the time of pessary removal and insertion reduces pain when compared to the use of placebo cream. Participants will be randomized to receive either 10 grams of 5% EMLA cream (4 mL) or 4 mL of placebo cream (aqueous cream BP). Cream will be applied in office at the time of pessary removal and insertion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
Loyola University Medical Center
Maywood, Illinois, United States
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Time frame: Removal of Pessary
VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training
Self-reported pain intensity at time of pessary removal after controlling for pessary type and investigator training level. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Time frame: Removal of Pessary
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age
Self-reported pain intensity at time of pessary removal after controlling for patient age and baseline pain score. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Time frame: Removal of Pessary
VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain
Practitioner's perception of patient's pain score at time of pessary insertion adjusting for baseline pain. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Time frame: Insertion of Pessary
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