NCT04249063

Brief Summary

The objective of this study is to assess the efficacy of a fundal block in reducing women's perception of pain during NovaSure endometrial ablation (EA) in an outpatient-based setting.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

2.4 years

First QC Date

January 26, 2020

Last Update Submit

April 30, 2023

Conditions

Pain

Keywords

Abnormal Uterine BleedingEndometrial AblationNovaSurePain

Outcome Measures

Primary Outcomes (1)

  • Intraoperative pain

    Thirty seconds into the active NovaSure EA procedure, all participants will be asked the same standardized question to rate their pain. The question will be posed by the registered nurse assisting the physician, and the women will score their perception of pain on a scale from 0 to 10 using the VAS.

    30 seconds into active ablation procedure

Secondary Outcomes (4)

  • Post-operative pain

    1 hour post-procedure

  • Rescue analgesics/and or sedation

    From time of active ablation procedure to discharge from unit (t = 0 sec to t = ~3hrs).

  • Adverse reactions

    From time of active ablation to discharge from unit ( t= 0 sec to t = ~3hrs).

  • Acceptability of the procedure

    Post-procedure prior to discharge (t = ~3hrs).

Study Arms (2)

Treatment Group

EXPERIMENTAL

NovaSure EA with an injection of local anaesthetic into the fundus. Paracervical block and procedural sedation as per usual.

Drug: Xylocaine 1 % and Normal Saline

Control Group

PLACEBO COMPARATOR

NovaSure EA with an injection of normal saline into the fundus. Paracervical block and procedural sedation as per usual.

Drug: Normal Saline

Interventions

Xylocaine 1 % and Normal SalineDRUG

3cc aliquots of local anaesthetic will be injected into the right and left cornual regions and centrally in the fundus. This will be achieved by using a flexible hysteroscopic needle.

Also known as: Local anaesthetic
Treatment Group
Normal SalineDRUG

3cc aliquots of normal saline will be injected into the right and left cornual regions and centrally in the fundus. This will be achieved by using a flexible hysteroscopic needle.

Also known as: Placebo
Control Group

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Abnormal uterine bleeding
  • Pre-menopausal as determined by the presence of menstrual cycles
  • Must have completed their family or have no desire to preserve fertility
  • Uterus and cervix must meet eligibility criteria; based on hysteroscopy exam performed by the physician prior to the ablation procedure
  • Must be a female participant 25-55 years of age

You may not qualify if:

  • Any uterine characteristics that preclude performing EA
  • Past allergic reactions to local anaesthetic
  • Weight \<50kg
  • Submucous fibroids requiring myomectomy
  • Lack of patient consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynaecology & Pediatric Associates

Regina, Saskatchewan, S4S 6X3, Canada

Location

MeSH Terms

Conditions

PainMetrorrhagia

Interventions

LidocaineSaline SolutionAnesthesia, Local

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic Processes

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Darrien Rattray, MD

    Saskatchewan Health Authority - Regina Area

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The patient (participant), physician (care provider), recovery nurse (outcomes assessor) and researcher team (investigator) will all be blinded to the intervention. Only the assisting nurse dedicated to procedural setup will be aware of the allocated intervention.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Associate Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 26, 2020

First Posted

January 30, 2020

Study Start

January 18, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)