PACTR202203895560162

Comparison of different pain relief methods in infertile women undergoing hysterosalpingography in Bayelsa State, South-South Nigeria: a randomised controlled trial

Dr. Peter Chibuzor Oriji·Not Applicable·Pan Africa Clinical Trials RegistryRecruiting
Study focus
Disease/Condition
Obstetrics and Gynecology
Sponsor & location
Primary sponsor
Dr. Peter Chibuzor Oriji
Location
Nigeria
Timeline & enrollment
Phase
Not Applicable
Start date
Apr 01, 2020
End date
Jan 01, 1900
Summary

Infertility is defined as the failure of a couple to conceive ≥12 months of regular unprotected intercourse. It affects 6.6% and 26.4% of reproductive-aged women. Tubal abnormalities account for 30–40% of cases of infertility. Hysterosalpingography is considered the initial diagnostic tool for assessment of tubal patency. Additionally, it can be useful in the diagnosis of intrauterine pathology.This randomised controlled trial is being conducted at the radiology departments and infertility clinics of the Federal Medical Centre, Yenagoa and Niger Delta University Teaching Hospital, Okolobiri, both in Bayelsa State, Nigeria. Three hundred and eighty infertile women undergoing hysterosalpingography will be enrolled in the study. Women in Group I will receive intramuscular diclofenac 75 mg (3 ml) and paracervical block with 3 ml of water for injection. Women in Group II will receive intramuscular diclofenac 75 mg (3 ml) and paracervical block with 2% lignocaine. Women in Group III will receive intramuscular diclofenac 75 mg (3 ml) and intrauterine instillation of 2% lignocaine. Women in Group IV will receive intramuscular diclofenac 75 mg (3 ml) and 5% lignocaine cream applied on the cervix.Infertile women referred for hysterosalpingography, and women that gave consent and completely filled the consent/questionnaire form will be included in the study.Exclusion criteria included abnormal uterine/vaginal bleeding before the procedure, on-going menstruation, pregnancy, discharge on inspection of the cervix, cervical stenosis/cervical pathology, evidence of pelvic inflammatory disease, previous history of contrast hypersensitivity, history of allergy to diclofenac and lignocaine, and all patients that declined consent.

ICD-10 classifications
Obstetric and gynaecological devices associated with adverse incidentsObstructed labour due to other maternal pelvic abnormalitiesObstetric and gynaecological devices associated with adverse incidents : miscellaneous devices, not elsewhere classifiedObstetric and gynaecological devices associated with adverse incidents : diagnostic and monitoring devicesOther complications of obstetric surgery and procedures
Data source
Registry
Pan Africa Clinical Trials Registry
Trial ID
PACTR202203895560162
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for PACTR202203895560162 through Pure Global AI's free database. This Not Applicable trial is sponsored by Dr. Peter Chibuzor Oriji and is currently Recruiting. The study focuses on Obstetrics and Gynecology.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Pan Africa Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.