2.5% Lidocaine/2.5% Prilocaine Cream for IUD Insertion and Endometrial Biopsy
A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of Self-application of Lidocaine 2.5%/Prilocaine 2.5% Cream for Intrauterine Device (IUD) Insertion and Endometrial Biopsy
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The proposed study is a double-blind, placebo-controlled randomized controlled trial (RCT). Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure and post-procedure survey will occur during the same visit.
Two separate randomization schedules will be generated, one for IUD insertion and one for endometrial biopsy, using computer-generated sequences prepared by an independent study coordinator. Randomization will occur via consecutively numbered, opaque, sealed envelopes containing the allocation code. Each participant will be randomly assigned to one of two arms: 1) Intervention (5g of 2.5% lidocaine/2.5% prilocaine cream in a pre-filled vaginal applicator). 2) Placebo (5g of VersaPro cream in a pre-filled vaginal applicator). The research coordinator (who is not involved in direct patient care) will open the allocation envelopes without the presence of the participant or the provider. They will prepare the self-applicators with either 5g of 2.5% lidocaine/2.5% prilocaine cream or 5g of placebo cream to maintain blinding. The patient will be instructed how to self-administer the applicator and dispense all 5g of cream into their vagina in the washroom. A patient education sheet highlighting instructions will also be provided. The patient will wait 10-15 mins and then will be brought into a room for the procedure. Once the procedure begins, pain scores at key intervals will be patient-reported by a 10-point numeric rating scale (NRS) and recorded by a research assistant. A global pain score using a 100mm visual analogue scale (VAS) at 5-minutes following the procedure will also be collected. Post-procedure, there will be a provider-completed questionnaire and a patient satisfaction questionnaire. The provider questionnaire will help describe details of the procedure and complications. The patient satisfaction questionnaire will describe feasibility, acceptability and satisfaction with self-administered cream. The primary outcome will be global pain score at 5-minutes post-procedure, which will be patient-reported by the 100 mm VAS. Secondary outcomes include: pain at specific pain points using a 10-point NRA (baseline after insertion of cream, after insertion of speculum, tenaculum placement, sounding of uterus (IUD only), IUD insertion or endometrial biopsy, and 1-minute post-procedure). Other secondary outcomes include pre- and post-procedure anxiety, procedural characteristics (uterine size, position, IUD type, number of biopsy passes), immediate complication and side effects, procedural difficulty, length of time to complete the procedure, and patient reported feasibility, acceptability, perceived control over pain and satisfaction.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Mara Sobel, MD
- 전화번호: 416-586-8273
- 이메일: mara.sobel@sinaihealth.ca
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G1Z5
- Ontario Power Generation Building
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연락하다:
- Mara Sobel, MD
- 전화번호: 416-586-8273
- 이메일: mara.sobel@sinaihealth.ca
-
수석 연구원:
- Mara Sobel, MD
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부수사관:
- Praniya Elangainesan, MD
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Any participant ≥18 years presenting for an IUD insertion or endometrial biopsy
- English speaking participants only
Exclusion Criteria:
- Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
- Misoprostol administration within 24 hours
- Confirmed pregnancy
- Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus)
- Allergy to lidocaine, prilocaine or any other "-caine" type anesthetics or any of the non-medicinal ingredients found in the product
- Patients with congenital or idiopathic methemoglobinemia
- Patients with glucose-6-phosphate dehydrogenase deficiency
- Severe kidney or liver disease
- Previous history of local anesthetic systemic toxicity (LAST)
- Baseline vital signs of systolic blood pressure <100, diastolic blood pressure <60 and/or pulse <60.
- Previous unsuccessful office attempt of IUD insertion or endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful IUD insertion or biopsy attempt by a different practitioner will still be eligible)
- Active atopic dermatitis or skin involving vulva, vagina and/or cervix.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Medicated cream
5g of 2.5% lidocaine/2.5% prilocaine topical cream administered with vaginal self-applicator
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5g of 2.5% lidocaine/2.5% prilocaine topical cream administered by participant by vaginal self-applicator
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위약 비교기: Placebo cream
5g of placebo VersaPro topical cream administered with vaginal self-applicator
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5g of VersaPro cream administered by participant by vaginal self-applicator
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Global pain score
기간: Completed by patient 5-minutes post procedure.
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Patient-reported pain measured using the 100-mm Visual Analogue Scale (VAS) 5 minutes following the procedure (endometrial biopsy or IUD insertion).
The VAS ranges from 0 mm (no pain) to 100 mm (worst pain imaginable), with higher scores indicating greater pain (a worse outcome).
|
Completed by patient 5-minutes post procedure.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain scores at specific pain points during procedure
기간: During the procedure
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Pain scores at specific pain points: baseline after insertion of cream, after insertion of the speculum, removal of excess cream with gauze, placement of tenaculum, sounding (IUD only), IUD insertion/endometrial biopsy, and 1-minute post-procedure, which will be patient-reported verbally during the procedure on a scale from 0 (i.e.
no pain) to 10 (worst pain imaginable).
When more than one biopsy pass is required, only pain after the first pass will be recorded.
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During the procedure
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Anxiety levels
기간: After application of the cream and waiting for 10 minutes but before starting the procedure as well as at 1-minute after the procedure.
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Patient-reported anxiety before and after the procedure, measured using a 5-point Likert scale ranging from 1 (very anxious) to 5 (very calm).
Higher scores indicate less anxiety (a better outcome).
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After application of the cream and waiting for 10 minutes but before starting the procedure as well as at 1-minute after the procedure.
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Immediate complications of endometrial biopsy and/or IUD insertion
기간: Completed by the provider immediately after the procedure (within 30 mins post procedure).
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Provider-reported immediate complications associated with the endometrial biopsy and/or IUD insertion, including difficulty of procedure, vasovagal reaction, vital sign changes, or other procedure-related complications.
This will be assessed by the presence or absence of specific procedure-related complications.
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Completed by the provider immediately after the procedure (within 30 mins post procedure).
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Difficulty of procedure
기간: Completed by the provider immediately after the procedure (within 30 mins post procedure).
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The difficulty of the procedure will be assessed with a Likert scale from 1 (least difficult) to 5 (most difficulty), provider reported.
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Completed by the provider immediately after the procedure (within 30 mins post procedure).
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Length of time for procedure completion
기간: During the procedure
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Time will be recorded via stopwatch
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During the procedure
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Patient-reported acceptability, feasibility, and satisfaction with vaginal cream self-administration
기간: Completed by the patient immediately after the procedure (within 30 mins post procedure).
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Patient-reported acceptability and satisfaction with self-administration will be assessed using a study-specific questionnaire evaluating ease and comfort of self-administration, perceived control, satisfaction with pain control and the self-application process, and willingness to use self-administration for a future gynecologic procedure. Ease of administration, comfort with self-administration, satisfaction with pain control, satisfaction with the self-application process, and likelihood of choosing self-administration again will each be assessed using 5-point Likert scales ranging from 1 to 5, with higher scores indicating greater ease, comfort, satisfaction, or likelihood of future use (a better outcome). Additional acceptability measures, including confidence in correct application, difficulty with application, perceived control, and willingness to choose the same pain-control method in the future, will be reported descriptively based on categorical responses (Yes/No/Unsure) |
Completed by the patient immediately after the procedure (within 30 mins post procedure).
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- REB # 1630
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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