Endometrial DiseasesPhase 4ICOBNCT01808898
Role of Intrauterine Cornual Block in Combination With Direct Cervical Block in Outpatient Endometrial Ablation
A Phase 4 study testing Local Anaesthetic in people with Endometrial Diseases, run by Birmingham Women's and Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Diseases
- What is being tested?
- Local Anaesthetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
Read the 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).
- Conditions
- Endometrial Diseases
- Being tested
- Local Anaesthetic
- Keywords
- Ablation, Outpatient
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local AnaestheticProcedure or surgery
Also called Mepivacaine and bupivacaine
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)
| Study group | Role | What they receive |
|---|---|---|
| Local anaesthetic | Experimental | 2mls consisting of 1ml of 3% mepivacaine (short / medium acting) and 1ml of 0.5% bupivacaine (long acting) Receives: Procedure: Local Anaesthetic |
| Saline | Placebo comparator | 2mls of Normal Saline solution in a 5ml syringe Receives: Procedure: Local Anaesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: administered immediately after the procedure
Secondary outcomes (1)
Visual Analogue scale evaluating pain
- To determine the effectiveness of intrauterine cornual block by evaluating pain using VAS at 1 hour after the procedure and prior to discharge from the hospital.
- To assess the total requirements for rescue analgesia in the first 24-hour post-operative period between the two groups.
Measured: 1 hour after procedure and at discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Janesh K Gupta, MSc MD FRCOG, Principal investigator, Birmingham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808898
- Sponsor's protocol ID
- 12/BWH/NO75
- Acronym
- ICOB
- Status last verified
- May 2015
- First submitted
- 24 Feb 2013
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kumar V, Tryposkiadis K, Gupta JK. Hysteroscopic local anesthetic intrauterine cornual block in office endometrial ablation: a randomized controlled trial. Fertil Steril. 2016 Feb;105(2):474-80.e1. doi: 10.1016/j.fertnstert.2015.10.019. Epub 2015 Nov 4.
PubMed 26546298
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01808898
- Acronym / sponsor ID
- ICOB / 12/BWH/NO75
- Conditions
- Endometrial Diseases
- Keywords
- Ablation, Outpatient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anaesthetic | Experimental | Procedure: Local Anaesthetic2mls consisting of 1ml of 3% mepivacaine (short / medium acting) and 1ml of 0.5% bupivacaine (long acting) |
| Saline | Placebo comparator | Procedure: Local Anaesthetic2mls of Normal Saline solution in a 5ml syringe |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local AnaestheticAlso: Mepivacaine and bupivacaineOn 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) | Procedure or surgery | Local anaesthetic, Saline |
Primary outcome
Visual Analogue scale evaluating pain
Time frame: administered immediately after the procedure
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.
1 secondary outcome
Visual Analogue scale evaluating pain
Time frame: 1 hour after procedure and at discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Derived from this study: PubMed 26546298Kumar V, Tryposkiadis K, Gupta JK. Hysteroscopic local anesthetic intrauterine cornual block in office endometrial ablation: a randomized controlled trial. Fertil Steril. 2016 Feb;105(2):474-80.e1. doi: 10.1016/j.fertnstert.2015.10.019. Epub 2015 Nov 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janesh K Gupta, MSc MD FRCOG principal investigator
Birmingham University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Local Anaesthetic in people with Endometrial Diseases, run by Birmingham Women's and Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue scale evaluating pain (time frame: administered immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01808898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.