Study looking at which local anaesthetic method (KAPT or paracervical) provides better pain relief for women attending the hysteroscopy clinic
| ISRCTN | ISRCTN15619382 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15619382 |
| IRAS number | 339976 |
| Secondary identifying numbers | IRAS 339976, REC 24/EM/0036 |
- Submission date
- 01/09/2024
- Registration date
- 05/09/2024
- Last edited
- 05/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
A hysteroscopy is a test to look inside a woman's womb using a thin tube with a small camera inside it. This study aims to evaluate and compare the pain scores of women undergoing outpatient hysteroscopy when administered either the KAPT block or paracervical block, with an emphasis on understanding the relative effectiveness of these two anaesthetic techniques at critical stages of the outpatient hysteroscopy procedure: during cervical dilatation, throughout the procedure, and 10 minutes after the procedure.
Who can participate?
Patients aged 18 years and over attending outpatient hysteroscopy,
What does the study involve?
Participants are randomly divided into two equal groups. One group will have a paracervical block and the other group will have a KAPT block. A questionnaire will be handed over during and after the procedure to assess pain and determine the effectiveness of each anaesthetic technique.
What are the possible benefits and risks of participating?
There are no additional risks associated with taking part in the study. However, there are some minor side effects of the procedures and these will be covered in the procedure consent process. For example, patients may experience a sharp scratch during administration of the local anaesthetic due to the injection needle. Some patients may experience some side effects of the local anaesthetic including tingling sensation, headaches, dizziness and visual disturbances. These are very rare and temporary and usually wear off within a few minutes.
Where is the study run from?
Sherwood Forest Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
October 2023 to August 2024
Who is funding the study?
Sherwood Forest Hospitals NHS Foundation Trust (UK)
Who is the main contact?
Dr Raphael Laiyemo, raphael.laiyemo@nhs.net
Contact information
Public, Scientific, Principal Investigator
Department of Obstetrics and Gynaecology
Kingsmill Hospital
Sherwood Forest Hospitals NHS Foundation Trust
Sutton-in Ashfield
NG17 4JL
United Kingdom
| Phone | +44 (0)1623622515 |
|---|---|
| raphael.laiyemo@nhs.net |
Study information
| Study design | Single-centre interventional single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Comparative analysis of pain relief between KAPT block and paracervical block for outpatient hysteroscopy procedures at Kings Mill Hospital: the KAPT-PARA block trial |
| Study acronym | KAPT-PARA block |
| Study hypothesis | To determine which method, KAPT block or paracervical block, offers superior pain relief at critical stages of the outpatient hysteroscopy procedure: during cervical dilatation, throughout the procedure, and 10 minutes post-procedure. This will involve a detailed analysis of pain scores at these specific time intervals. |
| Ethics approval(s) |
Approved 05/06/2024, Health Research Authority (HRA), Health and Care Research Wales (HCRW) (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048115; approvals@hra.nhs.uk), ref: IRAS 339976, REC 24/EM/0036 |
| Condition | Outpatient hysteroscopy procedures |
| Intervention | Paracervical Block for Outpatient Hysteroscopy Procedures is based on two key anaesthesia techniques: 1. KAPT Block: A sophisticated block targeting the Lee-Frankenhauser plexus, KAPT Block is effective in denervating the cervix and fundus. Its efficacy, demonstrated through observational studies, shows promising pain relief outcomes in outpatient hysteroscopy. 2. Paracervical Block (PCB): A commonly used technique in outpatient hysteroscopy, PCB's effectiveness is supported by a meta-analysis showing significant pain reduction. Although its superiority is debated, it remains a preferred method for pain control in these procedures. The study aims to compare effectiveness in pain management for outpatient hysteroscopy, thus addressing the gaps in current understanding and practice. Paracervical Block Technique: The primary technique involves injecting 10ml of Citanest into the cervical stroma at the cervicovaginal junction. This can be done in two ways: Four-point injection at 2, 4, 8, and 10 o'clock positions. Two-point injection at 4 and 8 o'clock positions only. KAPT Block Technique: 10 ml of Citanest 1. Inject 0.2 ml of Citanest directly into the cervical stroma at 6 and 12 o'clock to facilitate grasping with a tenaculum. 2. Measure 3 cm inferolateral from the external os towards 5 and 7 o'clock on both sides using a Pipelle sampler to locate the Lee-Frankenhauser plexus in the Uterosacral Ligament Complex (USLC). 3. Perform an inject-withdrawal technique, injecting a total of 4 ml at the measured sites on each side, distributed as follows: 3.1. 2 ml directly (Anterior to Posterior) at 5 o'clock and 7 o'clock. Sideways elevation of the lower lip of the cervix with a tenaculum can facilitate this step. 3.2. 2 ml from the medial to the lateral aspect at 5 o'clock and 7 o'clock, angling the syringe slightly for ease. 3.3. The depth of injection should be 25 mm, approximately ¾ of the length of the dental syringe needle. 4. The objective is to infiltrate the LF plexus in both the supero-inferior and lateral planes. 5. Allow a pause of at least 3 minutes before commencing the procedure. Research Question/Aim(s): How do the pain relief outcomes of the King's Mill Anterior-Posterior and Transverse (KAPT) Block compare to the Paracervical Block in women undergoing outpatient hysteroscopy procedures Objectives 1. To conduct a randomised control trial evaluating and comparing the pain scores of women undergoing outpatient hysteroscopy when administered either the KAPT Block or the Paracervical Block. 2. To determine which method, KAPT Block or Paracervical Block, offers superior pain relief at critical stages of the outpatient hysteroscopy procedure: during cervical dilatation, throughout the procedure, and 10 minutes post-procedure, through detailed analysis of pain scores at these specific intervals. The outpatient hysteroscopy procedures will include: Myosure removal of polyps Myosure removal of fibroids Thermablate endometrial ablation This study will be a randomized control trial, comparing the efficacy of KAPT Block and Paracervical Block in outpatient hysteroscopy. This approach will provide robust, comparative data on the effectiveness of these anaesthetic techniques. Data Collection Methods: Patient Questionnaires with Visual Pain Score: Patients will complete questionnaires with a visual analogue scale (VAS) 0 to 10 score to self-report their pain levels at various stages of the procedure (during cervical dilatation, the procedure itself, and 10 minutes post-procedure). This method allows for direct, objective assessment of pain from the patient's perspective. Data Analysis Methods: Quantitative Analysis: The collected pain scores will be statistically analysed to determine the effectiveness of each anaesthetic technique. This analysis will involve comparing mean pain scores and assessing variations in pain experiences among patients. Data Management: Data will be de-identified to maintain patient confidentiality. Electronic data will be securely stored and encrypted. Only authorized personnel will have access. Hard copies, if any, will be kept in a secure location. After the study, data will be archived as per institutional and legal guidelines. Software: Statistical software will be used for quantitative data analysis. Patient Public Involvement (PPI) PPI groups have been involved with the study proposal process. A number of patients were asked specific questions regarding the study design and purpose. All information has been stored for future reference and publication. A total of 10 patients were approached to complete a short questionnaire. The answers to the questionnaire concluded that 100 percent of patients agreed that the study would be beneficial and is an important subject. The vast majority of patients stated they would participate in the study and the information provided is clear and concise. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain measured using the visual analogue score (VAS), during the procedure and 10 minutes after completion of the procedure |
| Secondary outcome measures | Patient comfort and tolerability will be assessed by asking patients after each method by answering YES or NO in a questionnaire format if they will recommend it to others and if they were satisfied with the pain relief method provided |
| Overall study start date | 18/10/2023 |
| Overall study end date | 12/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Female |
| Target number of participants | 48 |
| Total final enrolment | 48 |
| Participant inclusion criteria | 1. Women attending outpatient hysteroscopy procedures at Kings Mill Hospital 2. Age 18 years and above 3. Willing to participate and able to provide informed consent |
| Participant exclusion criteria | 1. Women with known contraindications to local anaesthetics 2. Women with a history of allergic reactions to the anaesthetics used |
| Recruitment start date | 25/06/2024 |
| Recruitment end date | 12/08/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Mansfield Road
Sutton-in-ashfield
NG17 4JL
United Kingdom
Sponsor information
Hospital/treatment centre
Mansfield Road
Mansfield
NG17 4JL
England
United Kingdom
| Phone | +44 (0)1246622515 x 6929 |
|---|---|
| sfh-tr.researchandinnovation@nhs.net | |
| Website | http://www.sfh-tr.nhs.uk/ |
"ROR" |
https://ror.org/04ce87537 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 12/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and /or analysed during the current study will be stored in a publicly available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.0 | 16/04/2024 | 05/09/2024 | No | No |
Additional files
Editorial Notes
02/09/2024: Study's existence confirmed by the HRA.
