FUndal Block During NovaSure enDometrial AbLation to Reduce Intraoperative PAIN: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 288
- Locations
- 1
- Primary Endpoint
- Intraoperative pain
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 25 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Any uterine characteristics that preclude performing EA
- •Past allergic reactions to local anaesthetic
- •Weight <50kg
- •Submucous fibroids requiring myomectomy
- •Lack of patient consent
Arms & Interventions
Treatment Group
NovaSure EA with an injection of local anaesthetic into the fundus. Paracervical block and procedural sedation as per usual.
Intervention: Xylocaine 1 % and Normal Saline (Drug)
Control Group
NovaSure EA with an injection of normal saline into the fundus. Paracervical block and procedural sedation as per usual.
Intervention: Normal Saline (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Rescue analgesics/and or sedation(From time of active ablation procedure to discharge from unit (t = 0 sec to t = ~3hrs).)
- Acceptability of the procedure(Post-procedure prior to discharge (t = ~3hrs).)
- Post-operative pain(1 hour post-procedure)
- Adverse reactions(From time of active ablation to discharge from unit ( t= 0 sec to t = ~3hrs).)
Investigators
Darrien Rattray
Principal Investigator, Clinical Associate Professor, Department of Obstetrics and Gynecology
Saskatchewan Health Authority - Regina Area