Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano

NCT ID: NCT02918812

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-03-31

Brief Summary

This study compares the effect of intracervical block with 1% lidocaine and intramuscular diclofenac 75mg in decreasing pain perception during hysterosalpingography. Half of participants will receive intracervical block with 1% lidocaine, while the other half will receive intramuscular diclofenac 75mg.

Detailed Description

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

Conditions

Female Infertility of Tubal Origin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intracervical lidocaine

Intervention Type: DRUG

Intracervical lidocaine injected at four different points

Intramuscular Diclofenac

This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.

Group Type: ACTIVE_COMPARATOR

Intramuscular Diclofenac

Intervention Type: DRUG

Intramuscular Diclofenac 30 mins before HSG

Interventions

Intracervical lidocaine

Intracervical lidocaine injected at four different points

Intervention Type: DRUG

Intramuscular Diclofenac

Intramuscular Diclofenac 30 mins before HSG

Intervention Type: DRUG

Other Intervention Names

lignocaine; Diclofenac sodium; Voltaren

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayero University Kano, Nigeria

OTHER

Sponsor Role: lead

Responsible Party

Sulaiman Muhammaad Daneji

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sulaiman D Muhammad, MBBS

Role: PRINCIPAL_INVESTIGATOR

Aminu Kano Teaching Hospital

Locations

Aminu Kano Teaching Hospital

Kano, Kano State, Nigeria

Site Status: RECRUITING

Countries

Nigeria

Central Contacts

Sulaiman D Muhammad, MBBS

Role: CONTACT

smuhddane@yahoo.com

+238065305050

Facility Contacts

Sulaiman D Muhammad, MBBS

Role: primary

+2348065305050

References

Hamilton M. Infertilty. In Edmonds K (Editor). Dewhurst's Textbook of obstetrics and gynecology. 8th edition. John Wiley and sons ltd 2012 567-79.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 24359050 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22926800 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17197592 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17443612 (View on PubMed)

Sinnatamby CS editor. Last's Anatomy: Regional and Applied. 11th Edition. Edinburgh. Churchill Livingstone; 2006. P 311-6.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 12414003 (View on PubMed)

Simpson WL Jr, Beitia LG, Mester J. Hysterosalpingography: a reemerging study. Radiographics. 2006 Mar-Apr;26(2):419-31. doi: 10.1148/rg.262055109.

Reference Type: BACKGROUND

PMID: 16549607 (View on PubMed)

Other Identifiers

ONGDaneji1

Identifier Type: -

Identifier Source: org_study_id