Local Anaesthetic for Transvaginal Egg Collection in IVF

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: lignocaine; Drug: normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8014
      • The Fertility Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LA; Intravaginal and pre-peritoneal injection of 1% lignocaine into each side of the upper vagina under ultrasound guidance immediately prior to ultrasound guided transvaginal oocyte retrieval	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
Placebo Comparator: P; Intravaginal saline placebo injection into each side of upper vagina under ultrasound guidance immediately prior to transvaginal oocyte retrieval	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total dose of iv fentanyl used during oocyte collection	Length of oocyte collection (minutes)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Fertility Centre, New Zealand
• Investigators: Principal Investigator: Sarah A Wakeman, FRANZCOG, The Fertility Centre

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Study Completion (Actual): July 1, 2002

Study Registration Dates

• First Submitted: November 3, 2007
• First Submitted That Met QC Criteria: November 5, 2007
• First Posted (Estimate): November 6, 2007

Study Record Updates

• Last Update Posted (Estimate): November 6, 2007
• Last Update Submitted That Met QC Criteria: November 5, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: pain relief; oocyte retrieval; Local anaesthetic
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 01/12/180