Local Anaesthetic for Transvaginal Egg Collection in IVF

Infertility Clinical Trial

Official title:

A Randomised Controlled Trial of Intravaginal Lignocaine Injection Versus Placebo for Analgesia During Oocyte Recovery in an IVF Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554424
• Other study ID #: 01/12/180
• Status: Completed
• Phase: N/A
• First received: November 3, 2007
• Last updated: November 5, 2007
• Start date: March 2002
• Est. completion date: July 2002

Study information

• Verified date: November 2007
• Source: The Fertility Centre, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see whether injecting local anaesthetic into the vaginal tissues,just prior to transvaginal egg collection,will decrease the amount of pain experienced by women having their eggs collected on an IVF cycle. All women will also receive intravenous sedation as required as well as a sleeping tablet thirty minutes prior to the procedure which is our routine procedure for egg collection.

Description:

Transvaginal oocyte retrieval is the most common method of oocyte collection in IVF cycles. A variety of different methods are used to provide analgesia/anesthesia for oocyte collection. Our unit has always used an oral pre-medication followed by intravenous fentanyl during the procedure but this doesn't seem to provide adequate analgesia for some women. The aim of this study was to compare the addition of intravaginal local anaesthetic injection versus saline placebo to our usual analgesia regime to see whether less intravenous fentanyl was required and whether the women experienced less pain during oocyte collection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• About to undergo transvaginal oocyte retrieval

Exclusion Criteria:

• Already undergone oocyte retrieval and participated in study (i.e. 2nd or more oocyte collection procedure during study period)

• Allergy to lignocaine

• Oocytes only to be collected from one ovary

• Procedure expected to be exceptionally painful

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• lignocaine
20 mls of 1% lignocaine solution for injection, 10mls into each side of upper vagina, under ultrasound guidance immediately prior to transvaginal oocyte retrieval under ultrasound guidance from each ovary
• normal saline
20mls of normal saline solution, 10mls injected each side into upper vagina under ultrasound guidance, immediately prior to ultrasound guided transvaginal oocyte retrieval from each ovary

Locations

Country	Name	City	State
New Zealand	The Fertility Centre	Christchurch	Canterbury

Sponsors (1)

Lead Sponsor	Collaborator
The Fertility Centre, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total dose of iv fentanyl used during oocyte collection		Length of oocyte collection (minutes)
Secondary	Pain score (cm on a Visual Analogue Scale) at 6 different points during oocyte collection		Actual point in time
Secondary	Length of oocyte collection procedure		Time taken (minutes)
Secondary	Occurence of nausea or vomiting		During oocyte collection procedure
Secondary	Administration of atropine or anti -emetic		During oocyte collection procedure
Secondary	Time spent in recovery room		Time from end of oocyte collection until discharge home
Secondary	No of oocytes collected		During oocyte collection procedure
Secondary	Number of oocytes fertilised		Assessed 18 hours after oocyte collection
Secondary	Pregnancy outcome		7 weeks gestation
Secondary	Number of embryos frozen		Within 6 days of oocyte collection
Secondary	Pulse rate at beginning and end of egg collection		Point in time
Secondary	Maximum pulse rate during oocyte collection		Point in time during oocyte collection procedure