Randomized Double-blind Placebo Controlled Trial to Assess the Role of Intrauterine Cornual Block (ICOB) in Combination With Direct Cervical Block in Outpatient Endometrial Ablation
Outpatient local anaesthesic (LA) hysteroscopic intrauterine therapeutic interventions such
as endometrial ablation have gained wider acceptance in the last decade. However, pain
experienced during these procedures can be a disincentive and is the commonest reason for
the use of escalating levels of analgesia post procedure, which results in prolongation of
hospital stay and recovery. Various methods of LA have been studied including intrauterine
topical lignocaine or cervical block using topical lignocaine, paracervical block or
intracervical block. However, a single site block individually may not be sufficient to
control the pain completely due to inability of the one site block to affect the sensitivity
of the whole uterus, as the uterine fundus is effectively still unanaesthetised. This may
be due to the uterus receiving complex innervations from different nerve routes such as the
uterovaginal plexus, the Frankenhauser nerve plexuses, parasympathetic ganglia and the
thoracic nerve.
Therefore, it seems logical to use a direct cervical block to block the sensation through
uterovaginal plexus and use an additional deep myometrial block adjacent to each cornua to
directly block the thoracic nerve supply. To date, only one small observational study has
looked at the effect of such a combined block in relieving pain during outpatient
hysteroscopic procedures. Therefore, we propose to undertake a double blind randomised
controlled trial to address this question by comparing effectiveness of a standard direct
cervical block and intrauterine cornual block (ICOB) versus a direct cervical block and a
normal saline intrauterine cornual injection (control).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Visual Analogue scale evaluating pain
To determine the effectiveness of intrauterine cornual block by evaluating pain directly attributable to outpatient hysteroscopic endometrial ablation assessed by using an ungraduated 10 cm visual analogue scale (VAS) administered immediately after the procedure prior to shifting patient to the recovery unit.
administered immediately after the procedure
No
Janesh K Gupta, MSc MD FRCOG
Principal Investigator
Birmingham University
United Kingdom: National Institute for Health Research
12/BWH/NO75
NCT01808898
February 2013
May 2014
Name | Location |
---|