Intracervical Anesthesia and Pain Associated With Intraut... | NCT03111342

Studies
Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

NCT03111342

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Aug 1, 2019Actual

Enrollment

300Actual

Phase

Phase 4

Conditions

Pain, Acute
Anesthesia, Local
IUD Insertion Complication

Interventions

Anesthesia
Dry-needling

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Aug 30, 2018Actual

Completion Date

Aug 31, 2018Actual

First Submitted Date

Apr 3, 2017

First Submission Date that Met QC Criteria

Apr 6, 2017

First Posted Date

Apr 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2019

Last Update Posted Date

Aug 1, 2019Actual

Name	Class
University of Campinas, Brazil	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in nulligravida women.

Detailed Description

No prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of levonorgestrel-releasing intrauterine system (LNG-IUS), only in reducing pain associated with the tenaculum. It is known that the nulligravida women have 3 times more chance of presenting moderate / severe pain associated to LNG-IUS placement. A previous study showed that injectable intracervical anesthesia reduced the risk of moderate/severe pain by 40%. However, the anesthetic dose was small (36 mg of lidocaine) and the study did not evaluate only nulligravida women which are potential candidates for most pain relief benefit. Thus, the primary aim of this study is to evaluate the effect of intracervical anesthesia on pain scores immediately following LNG-IUS insertion in nulligravida women.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anesthesia	Experimental	A 2% lidocaine without vasoconstrictor injection into the cervix	Drug: Anesthesia
Dry-needling	Sham Comparator	A placement of thin needle into the cervix without substance injection	Procedure: Dry-needling
No intervention	No Intervention	No intervention for pain relief prior to LNG-IUS insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anesthesia	Drug	A 2% lidocaine without vasoconstrictor injection into the cervix	Anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain associated with LNG-IUS insertion using VAS	To evaluate pain scores using the visual analog scale (VAS)	Immediately following LNG-IUS insertion

Secondary Outcomes

Measure	Description	Time Frame
Pain associated with LNG-IUS insertion using face scale	To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)	Immediately following LNG-IUS insertion
Pain associated with tenaculum placement using VAS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 45 years;
That were never pregnant before;
That wants to use LNG-IUD;
Not pregnant at the time of insertion;
No haematological disease;
That do not have signs and / or symptoms of vaginal / cervical infection.

Exclusion Criteria:

Categories 3 and / or 4 for the use of LNG-IUD according to the medical eligibility criteria of the World Health Organization (WHO), users of illicit drugs and / or alcohol, allergy or contraindication to lidocaine, presence of chronic pelvic pain of any etiology, presence of cervical abnormality such as isthmus-cervical fibrosis or incompetence, surgery on the cervix, psychiatric disorders, chronic use of medications that could interfere with the pain threshold (such as antidepressants and anticonvulsants).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carolina S Vieira, MD, PhD	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Sao Paulo		Ribeirão Preto	São Paulo	14049-900	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The IPD will be collect using Redcap and will be kept in special file until analysis. Then, data will be summarized for analysis.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000758	Anesthesia
D008012	Lidocaine
D000079245	Dry Needling

Ancestor Terms

ID	Term
D000760	Anesthesia and Analgesia
D000083	Acetanilides
D000813	Anilides
D000577	Amides

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Quadruple

Masking Description

The care provider will open the randomization envelope and will do one of three possible approaches (a intracervical lidocaine injection, a intracervical dry needling or no intervention). Then, a second care provider will insert the intrauterine contraceptive (IUC) blinding for the approach of the first care provider. After IUC insertion, the latter care provider will assess the pain felt by the woman using proper scales. The woman will be also blinded to the approach used before IUC insertion.

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor