Lidocaine-prilocaine Cream as Analgesia for In-office Levator Muscle Trigger Point Injections
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen and Infants Hospital of Rhode Island
About this trial
Levator muscle trigger point injections (TPI) are a commonly performed procedure in the office for treatment of pelvic pain related to pelvic floor muscles. The most common concern related to in-office TPI is pain. Currently, there is limited information about which medications could reduce pain during TPI. Pain control during in-office gynecologic procedures is a very important topic, and doctors are researching possible options for pain control during these procedures. Lidocaine-prilocaine cream is U.S Food and Drug Administration (FDA) approved for use on the genital area as pretreatment for procedures involving needles. The purpose of this study is to assess if vaginal lidocaine-prilocaine cream reduces pain with TPI compared to a placebo cream.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years or older
Patients who are undergoing in-office levator muscle trigger point injection for myofascial pelvic pain
Able to give informed consent for the study
Disqualifiers
Documented allergy to lidocaine or prilocaine
Use of lidocaine or prilocaine within last 72 hours
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine-Prilocaine Cream 2.5-2.5%
DrugThis is the intervention cream. If randomized to this arm, 5 grams will be applied along the planned distribution of TPI approximately 10 minutes prior to the procedure.
Permeation-enhancing vanishing cream
Other interventionThis is the placebo cream. If randomized to this arm, 5 grams will be applied along the planned distribution of TPI approximately 10 minutes prior to the procedure.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: EMLA (lidocaine-prilocaine) CreamExperimental treatment 1 intervention
Group B: Placebo (compounding, inactive cream)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Procedural Pain score
Using a 100 mm visual analog scale (0 mm indicating no pain and 100 mm indicating severe and intolerable pain), the patients will be asked during the procedure to indicate their pain level. This will be considered their maximum perceived pain during the procedure itself.
Time frame
intra-procedureSecondary outcomes
1
Post-Procedure Pain score
Using a 100 mm visual analog scale (0 mm indicating no pain and 100 mm indicating severe and intolerable pain), the patients will be immediately post (0 minutes post procedure) to indicate their pain level. This will be considered their perceived pain immediately after the procedure.
Time frame
0 minutes post-procedure2
Patient satisfaction with analgesia
Immediately post-procedure, patient will be asked, "How satisfied were you with your pain control during your trigger point injections?" The answer format will be a 5-point satisfaction scale as follows: very satisfied, satisfied, neither, dissatisfied, very dissatisfied.
Time frame
0 minutes post-procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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