Trial to assess if pain after surgery to remove their womb via the vagina is reduced using local anaesthetic in addition to the usual general anaesthetic.
- Conditions
- Pain suffered in the first 24 hours post vaginal hysterectomyMedDRA version: 17.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865MedDRA version: 17.0Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-004124-11-GB
- Lead Sponsor
- King's College Hospital NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 153
1. Female patient aged 18 years
2. Patients who will be undergoing vaginal hysterectomy
3. Capable of written informed consent in English
4. Patient is willing and able to complete pain scale questionnaire correctly
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 206
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. Patients undergoing any other concomitant procedure including and not limited to:
-Any abdominal incisions e.g. laparoscopy/laparotomy;
-Simultaneous mid-urethral tape insertion;
-Concomitant sacrospinous ligament fixation
(Vaginally applied uterosacral plication and McCall’s culdoplasty can be considered routine steps of a vaginal hysterectomy and are not reasons to exclude. Simultaneous pelvic floor repair is also not a reason to exclude);
2. Any patient who will receive a regional block e.g. Epidural, spine or TAP block
3. Patients with previous pelvic irradiation;
4. Patients with a history of previous pelvic floor surgery;
5. Patients who are allergic to analgesia on the international standardised post-operative analgesic prescription;
6. Patients using patient-controlled analgesia;
7. Patients who are allergic to local anaesthesia/adrenaline;
8. Patients who are already taking regular analgesia for chronic pain e.g. back or hip pain;
9. Patients taking anti-coagulation pre-operatively which would be highly active during the operation e.g. Aspirin/Clopidogrel five days prior to the operation date or Low-Molecular-Weight Heparin on day of the operation;
10. Patients treated with class III anti-arrhythmic drugs (e.g. Amiodarone);
11. Patients with partial or complete heart block – due to the fact that local anaesthetics may depress myocardial conduction;
12. Patients with advanced liver disease or severe renal dysfunction;
13. Any patient deemed unsafe for local anaesthetic by the anaesthetist;
14. Any patient who will receive Halogenate general anaesthesia for this pelvic floor surgery; and
15. Any patient who is pregnant; every patient who has consented for an elective hysterectomy will not be pregnant.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does the injection of local anaesthetic and adrenaline solution into the superficial tissue around the uterine cervix during vaginal hysterectomy reduce post-operative pain?;Secondary Objective: Does the injection of local anaesthetic and adrenaline (LA) solution into the superficial tissue of the uterine cervix during vaginal hysterectomy reduce blood loss during the operation, operating time, duration of inpatient stay and the incidence of post-operative infection and blood loss.;Primary end point(s): Change in pain score from Short-form McGill Pain questionnaire;Timepoint(s) of evaluation of this end point: 1. 3-6 hours post-operation<br>2. 24 hours post-operation
- Secondary Outcome Measures
Name Time Method