Local Anaesthetic for Transvaginal Egg Collection in IVF - Full Text View

Purpose

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.

Condition	Intervention
Infertility	Drug: lignocaine Drug: normal saline


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	A Randomised Controlled Trial of Intravaginal Lignocaine Injection Versus Placebo for Analgesia During Oocyte Recovery in an IVF Cycle

Resource links provided by NLM:

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by The Fertility Centre, New Zealand:

Primary Outcome Measures:

Total dose of iv fentanyl used during oocyte collection [ Time Frame: Length of oocyte collection (minutes) ]

Secondary Outcome Measures:

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


Enrollment:	75
Study Start Date:	March 2002
Study Completion Date:	July 2002

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554424

Locations


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

Sponsors and Collaborators

The Fertility Centre, New Zealand

Investigators


Principal Investigator:	Sarah A Wakeman, FRANZCOG	The Fertility Centre

More Information


ClinicalTrials.gov Identifier:	NCT00554424 History of Changes
Other Study ID Numbers:	01/12/180
Study First Received:	November 3, 2007
Last Updated:	November 5, 2007

Keywords provided by The Fertility Centre, New Zealand:


oocyte retrieval pain relief Local anaesthetic

Additional relevant MeSH terms:


Infertility Genital Diseases, Male Genital Diseases, Female Anesthetics Lidocaine Anesthetics, Local Central Nervous System Depressants Physiological Effects of Drugs	Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2017