Role of Intrauterine Cornual Block in Combination With Direct Cervical Block in Outpatient Endometrial Ablation
Condition: Endometrial Diseases
MeSH terms: Uterine Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The usual intervention to control the pain during an outpatient endometrial ablation has been
      to use local anaesthesia (LA) injection just in the neck of the womb (cervix). However, this
      alone may not be sufficient to control the pain completely. Therefore, we want to find out
      whether an injection of LA given deep into the muscle of the womb (myometrium), in addition
      to that in the cervix, has a better effect on controlling the pain during the procedure.

      All women attending gynaecology outpatient clinics, who have consented for an outpatient
      hysteroscopic procedure, will be invited to take part in the study. The study will be carried
      out in the outpatient hysteroscopy clinic at Birmingham Women's Hospital.

      As part of standard pain control method during an outpatient endometrial ablation, all women
      will receive an injection of LA in the cervix of the uterus to 'freeze it'. During
      hysteroscopy a randomly selected treatment group will receive an injection into deep muscle
      containing only normal saline (control group) whereas the experiment group will receive fast
      / long acting local anaesthesia (cornual block).

      Women will be asked to rate the degree of pain by placing a mark on an ungraduated 10 cm
      horizontal line. These scales will be given before the procedure, during LA injection,
      immediately after, one hour and at the time of discharge from hospital.

      The results will help future patients undergoing a similar procedure to have much better pain
      relief and allow many more to have the procedure without the side effects of a general
      anaesthetic and its risks. In addition to having less pain, it may reduce the number of
      painkillers needed as well as any stay in hospital. In future this may also allow a greater
      variety of procedures to be done in an outpatient setting.
    

Detailed description: 
      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).
    

Intervention name(s): Local Anaesthetic
Intervention type(s): Procedure
Intervention description(s): On the day of the procedure and before the patients are treated, a designated clinician will draw up the local anaesthetic (2mls consisting of 1ml of 3% mepivacaine (short / medium acting) and 1ml of 0.5% bupivacaine (long acting)
Other intervention name(s): Mepivacaine and bupivacaine
Intervention MeSH terms: Bupivacaine; Anesthetics, Local; Mepivacaine; Anesthetics
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ablation; Outpatient