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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

Phase 4
18 Years
50 Years
Open (Enrolling)
Endometrial Diseases

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Trial Information

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).

Inclusion Criteria:

- All women between the ages of 18 - 50 years presenting to the gynaecology outpatient
clinic scheduled for an outpatient hysteroscopic intrauterine therapeutic
intervention such as endometrial ablation.

Exclusion Criteria:

- Women with contraindications to hysteroscopic procedures such as atypical endometrial
hyperplasia or endometrial cancer, undiagnosed abnormal vaginal bleeding, current
lower pelvic infection or uterine abnormalities

- Women who are allergic to local anaesthesia

- Not technically possible to perform a hysteroscopy e.g. women with distorted
uterine cavity due to large fibroids

- Women considered vulnerable (e.g. current mental illness, emotionally labile, or
learning difficulties)

- Women who decline to be randomised and request the additional anaesthetic or
decline it will form a separate group to be studied and will be administered the
VAS similar to the trial group. This group will be analysed separately to
determine whether they are significantly different to those patients who consent
to being part of the trial.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Visual Analogue scale evaluating pain

Outcome Description:

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.

Outcome Time Frame:

administered immediately after the procedure

Safety Issue:


Principal Investigator

Janesh K Gupta, MSc MD FRCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Birmingham University


United Kingdom: National Institute for Health Research

Study ID:




Start Date:

February 2013

Completion Date:

May 2014

Related Keywords:

  • Endometrial Diseases
  • Ablation
  • Outpatient
  • Adenoma
  • Uterine Diseases