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Clinical trial

FUndal Block During NovaSure enDometrial AbLation to Reduce Intraoperative PAIN: A Randomized Controlled Trial

ID
Name
SaskHealthAuthority
Description
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 arms
Trial start
2021-01-18
Estimated PCD
2023-06-01
Trial end
2023-06-01
Status
Active (not recruiting)
Treatment
Xylocaine 1 % and Normal Saline
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.
Arms:
Treatment Group
Other names:
Local anaesthetic
Normal Saline
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.
Arms:
Control Group
Other names:
Placebo
Size
288
Primary endpoint
Intraoperative pain
30 seconds into active ablation procedure
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 288, 'type': 'ESTIMATED'}}
Updated at
2023-05-03

1 organization

1 product

1 drug

1 indication

Organization
Saskatchewan Health Authority - Regina Area
Product
Xylocaine
Indication
Pain
Drug
Varlilumab