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.

Double blind randomised multicentre study to assess the effect of local anaesthesia during vaginal hysterectomy - Effect of local anaesthesia during vaginal hystectomy on post-op pain

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004124-11-GB

Enrollment

206

Registered

2014-05-21

Start date

2014-08-11

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain suffered in the first 24 hours post vaginal hysterectomy MedDRA version: 17.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865 MedDRA version: 17.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Bupivicaine and Adrenaline Injection Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intracervical use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 2. 24 hours post-operation	—

Measure

Time frame

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 2. 24 hours post-operation

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Secondary

Measure	Time frame
Secondary end point(s): 1. Estimated operative blood loss (EBL) from operating surgeon. 2. Change in pre and post-operative Hb and Hct as a marker of EBL 3. A visual analogue scale (VAS) assessing surgeon's perception of ease of dissection and ooze. 4. Time from knife to skin to end of operation for operating time 5. Duration of inpatient stay in days where 1 day would mean patient discharged any time the day after surgery etc. 6. Incidence of post-operative morbidity: -Febrile morbidity most likely of vaginal/pelvic origin excluding UTI -Pelvic haematoma -Return to theatre;Timepoint(s) of evaluation of this end point: 1. Estimated operative blood loss (EBL)- all surgeons will document this immediately post-operatively 2. Change in pre and day 1 post-operative Hb and Hct as a marker of EBL 3. A visual analogue scale (VAS) completed by the operating surgeon immediately after the operation to state their perception of ease of dissection and ooze. 4. Time from knife to skin to end of operation for operating time 5. Duration of inpatient stay in days where 1 day would mean patient discharged any time the day after surgery etc. Tpo be completed in CRF once patient has been discharged off the ward. 6.Incidence of post-operative morbidity. To be completed after 6 weeks post-op. -Febrile morbidity most likely of vaginal/pelvic origin excluding UTI -Pelvic haematoma -Return to theatre	—

Measure

Time frame

Secondary end point(s): 1. Estimated operative blood loss (EBL) from operating surgeon. 2. Change in pre and post-operative Hb and Hct as a marker of EBL 3. A visual analogue scale (VAS) assessing surgeon's perception of ease of dissection and ooze. 4. Time from knife to skin to end of operation for operating time 5. Duration of inpatient stay in days where 1 day would mean patient discharged any time the day after surgery etc. 6. Incidence of post-operative morbidity: -Febrile morbidity most likely of vaginal/pelvic origin excluding UTI -Pelvic haematoma -Return to theatre;Timepoint(s) of evaluation of this end point: 1. Estimated operative blood loss (EBL)- all surgeons will document this immediately post-operatively 2. Change in pre and day 1 post-operative Hb and Hct as a marker of EBL 3. A visual analogue scale (VAS) completed by the operating surgeon immediately after the operation to state their perception of ease of dissection and ooze. 4. Time from knife to skin to end of operation for operating time 5. Duration of inpatient stay in days where 1 day would mean patient discharged any time the day after surgery etc. Tpo be completed in CRF once patient has been discharged off the ward. 6.Incidence of post-operative morbidity. To be completed after 6 weeks post-op. -Febrile morbidity most likely of vaginal/pelvic origin excluding UTI -Pelvic haematoma -Return to theatre

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Countries

United Kingdom

Contacts

Public ContactProf Linda Cardozo

KCH NHS Foundation Trust

linda.cardozo@nhs.net00442032993000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026