- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02918812
Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano
The Effect of Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief During Hysterosalpingography Among Infertile Women In A Tertiary Hospital In Kano: A Randomized Controlled Trial
연구 개요
상세 설명
Hysterosalpingography (HSG) is a radiographic test to evaluate the contour of the uterine cavity and patency of the fallopian tubes after injection of a radio-opaque dye through the cervix. It is typically performed in the evaluation of infertility or to diagnose uterine anomalies. It is the most common method of tubal evaluation in the developing countries because it is cheap, readily available and requires less expertise. Unfortunately, HSG can cause discomfort or pain for the patient during or after the procedure, and this evokes anxiety and fear for many patients. Up to 72 % of women complain of significant discomfort with this test.
Lidocaine is a local anaesthetic which exerts its effect by altering neuronal depolarization by blocking the sodium channels in the cell membrane, thereby preventing transmission of the sensation of pain to the higher neurons. Lidocaine is commonly used for infiltration and for peripheral nerve blocks if an intermediate duration is required.
Diclofenac is a Non-steroidal anti inflammatory drug that reduce nociception which is related to inflammation and inflammatory mediators whether from trauma
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Sulaiman D Muhammad, MBBS
- 전화번호: +238065305050
- 이메일: smuhddane@yahoo.com
연구 장소
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Kano State
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Kano, Kano State, 나이지리아
- 모병
- Aminu Kano Teaching Hospital
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연락하다:
- Sulaiman D Muhammad, MBBS
- 전화번호: +2348065305050
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수석 연구원:
- Sulaiman D Muhammad, MBBS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All women with infertility who will be undergoing a hysterosalpingography, and must have given consent will be recruited into the study
Exclusion Criteria:
- History of any allergies to local anaesthetics, radio-opaque dye, or anti-inflammatory medications
- All patients with active pelvic inflammatory diseases
- All patients with chronic pelvic pain
- Patients with history of cervical surgery
- Other indications for hysterosalpingography like Ashermans syndrome, congenital uterine anomalies
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intracervical lidocaine
This group will comprise of patients that will receive the intracervical block.
The study group will receive a total of 60 mg (6 mL) of 1% lidocaine to be injected at four points (12, 4, 6, and 8 o'clock) circumferentially into the cervix (1.5 mL at each point) 5 minutes before proceeding with the hysterosalpingogram.
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Intracervical lidocaine injected at four different points
다른 이름들:
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활성 비교기: Intramuscular Diclofenac
This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.
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Intramuscular Diclofenac 30 mins before HSG
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Visual Analogue Score
기간: Preprocedure and procedure time 0
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A detailed description of the visual analogue scale (VAS) will be given personally to each woman prior to the procedure.
The VAS included a 10 cm linear scale on which 0 represents 'no pain' and 10 represents 'worst pain imaginable'.
All patients will be asked to grade their perceived lower abdominal pain levels during specified stages of HSG using the VAS as explained to them.
The scale will be used at different stages of the procedure: (1) before beginning the procedure; (2) after speculum application but before instrumentation; (3) after the application of the tenaculum and metal cannula and just before the injection of contrast medium; (4) at the end of uterine filling with contrast medium;
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Preprocedure and procedure time 0
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2차 결과 측정
결과 측정 |
기간 |
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patient's satisfaction with pain relief in the two groups using Likert scale
기간: Time Frame: 30 minutes post procedure and 24 hours post procedure
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Time Frame: 30 minutes post procedure and 24 hours post procedure
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Change in pain score from pre-procedure to 5 and 30 minutes post procedure
기간: 5 minutes and 30 minutes
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5 minutes and 30 minutes
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Change in pain score from pre-procedure to 5 and 24 hours post procedure
기간: 5 minutes and 24 hours
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5 minutes and 24 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sulaiman D Muhammad, MBBS, Aminu Kano Teaching Hospital
간행물 및 유용한 링크
일반 간행물
- Costello MF, Horrowitz S, Steigrad S, Saif N, Bennett M, Ekangaki A. Transcervical intrauterine topical local anesthetic at hysterosalpingography: a prospective, randomized, double-blind, placebo-controlled trial. Fertil Steril. 2002 Nov;78(5):1116-22. doi: 10.1016/s0015-0282(02)03362-9.
- Hamilton M. Infertilty. In Edmonds K (Editor). Dewhurst's Textbook of obstetrics and gynecology. 8th edition. John Wiley and sons ltd 2012 567-79.
- Hacivelioglu S, Gencer M, Cakir Gungor A, Kosar S, Koc E, Cosar E. Can the addition of a paracervical block to systemic or local analgesics improve the pain perceived by the patient during hysterosalpingography? J Obstet Gynaecol. 2014 Jan;34(1):48-53. doi: 10.3109/01443615.2013.828025.
- Chauhan MB, Lakra P, Jyotsna D, Nanda S, Malhotra V. Pain relief during hysterosalpingography: role of intracervical block. Arch Gynecol Obstet. 2013 Jan;287(1):155-9. doi: 10.1007/s00404-012-2515-z. Epub 2012 Aug 28.
- Robinson RD, Casablanca Y, Pagano KE, Arthur NA, Bates GW, Propst AM. Intracervical block and pain perception during the performance of a hysterosalpingogram: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):89-93. doi: 10.1097/01.AOG.0000247645.52211.41.
- Ahmad G, Duffy J, Watson AJ. Pain relief in hysterosalpingography. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD006106. doi: 10.1002/14651858.CD006106.pub2.
- Sinnatamby CS editor. Last's Anatomy: Regional and Applied. 11th Edition. Edinburgh. Churchill Livingstone; 2006. P 311-6.
- Simpson WL Jr, Beitia LG, Mester J. Hysterosalpingography: a reemerging study. Radiographics. 2006 Mar-Apr;26(2):419-31. doi: 10.1148/rg.262055109.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ONGDaneji1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
난관 기원의 여성 불임에 대한 임상 시험
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Intracervical lidocaine에 대한 임상 시험
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BioplusAsan Medical Center; Seoul National University Hospital; Soonchunhyang University Hospital초대로 등록
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