PainFUNDAL-PAINNCT04249063
Fundal Block in Pre-menopausal Women to Reduce Pain During Outpatient-based Endometrial Ablation (FUNDAL-PAIN)
A study testing Xylocaine 1 % and Normal Saline and Normal Saline in people with Pain, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Xylocaine 1 % and Normal Saline and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jan 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Any uterine characteristics that preclude performing EA
- Past allergic reactions to local anaesthetic
- Weight <50kg
- Submucous fibroids requiring myomectomy
- Lack of patient consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FUndal Block During NovaSure enDometrial AbLation to Reduce Intraoperative PAIN: A Randomized Controlled Trial
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.
Read the detailed description
The researchers aim to determine whether participants receiving the paracervical and fundal block (experimental group) achieve clinically and statistically significant reductions in self-reported pain during NovaSure EA, as compared to those receiving paracervical block (control group). All women will obtain concurrent procedural sedation. Women's perception of pain will be recorded on a scale from 0 to 10 using the visual analogue scale (VAS).
The researchers hypothesize that the participants receiving combined paracervical and fundal block will experience less pain during the active procedure, as compared to those receiving paracervical block alone.
- Conditions
- Pain
- Being tested
- Xylocaine 1 % and Normal Saline, Normal Saline
- Keywords
- Abnormal Uterine Bleeding, Endometrial Ablation, NovaSure, Pain
- Medical subject headings
- Pain, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylocaine 1 % and Normal SalineDrug
Also called Local anaesthetic
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.
Normal SalineDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | NovaSure EA with an injection of local anaesthetic into the fundus. Paracervical block and procedural sedation as per usual. Receives: 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 seconds into active ablation procedure
Secondary outcomes (4)
Post-operative pain
Using the VAS, all participants will be asked to rate their pain 1 hour post-procedure.
Measured: 1 hour post-procedure
Rescue analgesics/and or sedation
The use of additional rescue analgesics/and or sedation during the active ablation procedure and post-operative period will be recorded and compared between groups.
Measured: From time of active ablation procedure to discharge from unit (t = 0 sec to t = ~3hrs).
Adverse reactions
Any adverse reactions that occur in response to the fundal injections during and following the procedure will be recorded and compared between groups.
Measured: From time of active ablation to discharge from unit ( t= 0 sec to t = ~3hrs).
Acceptability of the procedure
The acceptability of the ablation procedure will be evaluated between groups by asking each participant if they would recommend the procedure to a friend.
Measured: Post-procedure prior to discharge (t = ~3hrs).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start18 Jan 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saskatchewan Health Authority - Regina Area
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darrien Rattray, Saskatchewan Health Authority - Regina Area
- Investigators
- Darrien Rattray, MD, Principal investigator, Saskatchewan Health Authority - Regina Area
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249063
- Sponsor's protocol ID
- SaskHealthAuthority
- Acronym
- FUNDAL-PAIN
- Status last verified
- Apr 2023
- First submitted
- 26 Jan 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FUndal Block During NovaSure enDometrial AbLation to Reduce Intraoperative PAIN: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04249063
- Acronym / sponsor ID
- FUNDAL-PAIN / SaskHealthAuthority
- Conditions
- Pain
- Keywords
- Abnormal Uterine Bleeding, Endometrial Ablation, NovaSure, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Saskatchewan Health Authority - Regina AreaUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The researchers aim to determine whether participants receiving the paracervical and fundal block (experimental group) achieve clinically and statistically significant reductions in self-reported pain during NovaSure EA, as compared to those receiving paracervical block (control group). All women will obtain concurrent procedural sedation. Women's perception of pain will be recorded on a scale from 0 to 10 using the visual analogue scale (VAS).
The researchers hypothesize that the participants receiving combined paracervical and fundal block will experience less pain during the active procedure, as compared to those receiving paracervical block alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Xylocaine 1 % and Normal SalineNovaSure EA with an injection of local anaesthetic into the fundus. Paracervical block and procedural sedation as per usual. |
| Control Group | Placebo comparator | Drug: Normal SalineNovaSure EA with an injection of normal saline into the fundus. Paracervical block and procedural sedation as per usual. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Any uterine characteristics that preclude performing EA
- Past allergic reactions to local anaesthetic
- Weight <50kg
- Submucous fibroids requiring myomectomy
- Lack of patient consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xylocaine 1 % and Normal SalineAlso: Local anaesthetic3cc 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. | Drug | Treatment Group |
| Normal SalineAlso: Placebo3cc 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. | Drug | Control Group |
Primary outcome
Intraoperative pain
Time frame: 30 seconds into active ablation procedure
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.
4 secondary outcomes
Post-operative pain
Time frame: 1 hour post-procedure
Rescue analgesics/and or sedation
Time frame: From time of active ablation procedure to discharge from unit (t = 0 sec to t = ~3hrs).
Adverse reactions
Time frame: From time of active ablation to discharge from unit ( t= 0 sec to t = ~3hrs).
Acceptability of the procedure
Time frame: Post-procedure prior to discharge (t = ~3hrs).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darrien Rattray, MD principal investigator
Saskatchewan Health Authority - Regina Area
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylocaine 1 % and Normal Saline and Normal Saline in people with Pain, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative pain (time frame: 30 seconds into active ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.