Clinical trial NCT00554424: Local Anaesthetic for Transvaginal Egg Collection in IVF
Official title: A Randomised Controlled Trial of Intravaginal Lignocaine Injection Versus Placebo for Analgesia During Oocyte Recovery in an IVF Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: oocyte retrieval
pain relief
Local anaesthetic
Lead sponsor: The Fertility Centre, New Zealand
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 75
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total dose of iv fentanyl used during oocyte collection
timeFrame: Length of oocyte collection (minutes)
Secondary outcomes:
measure: Pain score (cm on a Visual Analogue Scale) at 6 different points during oocyte collection
timeFrame: Actual point in time
measure: Length of oocyte collection procedure
timeFrame: Time taken (minutes)
measure: Occurence of nausea or vomiting
timeFrame: During oocyte collection procedure
measure: Administration of atropine or anti -emetic
timeFrame: During oocyte collection procedure
measure: Time spent in recovery room
timeFrame: Time from end of oocyte collection until discharge home
measure: No of oocytes collected
timeFrame: During oocyte collection procedure
measure: Number of oocytes fertilised
timeFrame: Assessed 18 hours after oocyte collection
measure: Pregnancy outcome
timeFrame: 7 weeks gestation
measure: Number of embryos frozen
timeFrame: Within 6 days of oocyte collection
measure: Pulse rate at beginning and end of egg collection
timeFrame: Point in time
measure: Maximum pulse rate during oocyte collection
timeFrame: Point in time during oocyte collection procedure
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: The Fertility Centre
state: Canterbury
Study officials:
affiliation: The Fertility Centre
name: Sarah A Wakeman, FRANZCOG
role: PRINCIPAL_INVESTIGATOR
References: