Ethyl Chloride Spray Versus Subcutaneous Lidocaine Anaesthetic Prior to Contraceptive Implant Insertion

Study Looking at Acceptability of Using Ethyl Chloride Spray Versus Subcutaneous Lidocaine Anaesthetic Prior to Contraceptive Implant Insertion

Study to look at the acceptability of local anaesthetic spray versus injection, prior to contraceptive implant insertion

Study Overview

• Status: Withdrawn
• Conditions: Contraception
• Intervention / Treatment: Other: Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant

Detailed Description

Currently, patients undergoing contraceptive implant insertion are offered local anaesthetic with an injection before insertion. This study aims to look at whether patients find using the local anaesthetic spray more acceptable or equally acceptable to using local anaesthetic injection. Both are currently licensed products for use as skin anaesthesia but the spray is potentially quicker and involves less injections. Some areas of sexual health are already offering this option but there isn't much evidence as to which patients find more acceptable.

Patients in this study will be given a choice of anaesthetic asked to complete a short questionnaire, giving a pain score , on the pain rating scale of 0 to 10, ( being no pain to 10 being extremely painful. ) In addition, they will be asked to give the reasons for their choice. The questionnaire will be anonymous.

Average pain scores will be calculated between in group and compared.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patient who choose to use the contraceptive implant as a method of contraception and who are deemed medically eligible for the method with no medical contrainidications

Description

Inclusion Criteria:

• Patient has chosen to use the implant as a method of contraception
• Patients will be assessed for medical eligibility for the contraceptive implant have no contraindications to either the implant, lidocaine or the ethyl chloride spray. However, if they have a known sensitivity to either the spray or the lidocaine ejection, they will be offered the other.
• Age between 13 and 55
• Has capacity to consent
• Has read the information sheet and consents to the study
• This will be offered for insertions of implant only i.e. not implant removals

Exclusion Criteria:

• Has a contraindication to have a contraceptive implant
• Doesn't wish to have a implant
• Allergy to either the implant, the lidocaine, the ethyl chloride or any of the incipient ingredients. Although patients will be given the option, if they have an allergy/contraindication to one of the products, they will be offered the other
• Is under 13 or over 55

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
local anaesthetic spray group; women will either chose the above, ethyl chloride spray prior to having their contraceptive implant fitted or the below injection. This comes in a canister and a maximum of 5 spray for 5 seconds will be applied topically to the skin at the site of the contraceptive implant insertion	Other: Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant
local anaesthetic injection group; women will either chose ethyl chloride spray prior to having their contraceptive implant fitted or the injection, subcutaneous 1% lidocaine, usually a dose of about 1-2 mls to the area skin where the contraceptive implant is to be inserted.	Other: Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion	Questionnaire based study looking at pain scores on the numeric pain rating scale 0 to 10, 0 being no pain to 10 being extremely painful	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion	Questionnaire looking at the reasons why women chose to use the injection or the spray	one year

Collaborators and Investigators

• Sponsor: Tayside Medical Science Centre

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: January 7, 2016
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 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; Reproductive Control Agents; Lidocaine; Contraceptive Agents; Ethyl Chloride
• Other Study ID Numbers: 2015OB09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No