Office-based Endometrial Sampling ProceduresNCT04572828
Effectiveness of Paracervical Block in Endometrial Sampling Procedures for Pain Control
A study testing Paracervical Block, 550 mg Naproxen Sodium 60 minutes before the procedure and The capped needle in people with Office-based Endometrial Sampling Procedures, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Office-based endometrial procedures are preferred over diagnostic dilation and curettage, nowadays. Paracervical block is single-shot nerve block that involve a one-time injection of local anesthetic adjacent to the utero-vaginal nerve plexus. Read more about this study
- Who is it for?
- Ages 35 to 80 years, women only
- Conditions the study is for
- Office-based Endometrial Sampling Procedures
- What is being tested?
- Paracervical Block, 550 mg Naproxen Sodium 60 minutes before the procedure and The capped needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2020to 28 Dec 2020
- Phase
- Interventional
- 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 35 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abnormal uterine bleeding
Who cannot join
- Pregnancy
- Pelvic infections
- Heavy bleeding disorders
- NSAID allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Paracervical Block in Endometrial Sampling Procedures for Pain Control: A Randomized Controlled Clinical Trial
Office-based endometrial procedures are preferred over diagnostic dilation and curettage, nowadays. Paracervical block is single-shot nerve block that involve a one-time injection of local anesthetic adjacent to the utero-vaginal nerve plexus. Block provides analgesia during cervical pass of sampling device or manipulation of cervix. The paracervical block seems to work within few minutes after injection, but the optimal waiting time between injection and procedure is not known. In this randomized controlled study, it was aimed to determine the effect of waiting time of 1 minute and 3 minutes after paracervical block in endometrial sampling procedures using Pipelle cannula in terms of pain during and after the endometrial sampling and to compare with NSAIDs taken before the procedure.
Read the detailed description
120 participants who will undergo endometrial biopsy due to abnormal uterine bleeding will be enrolled in the study. The research will be conducted in 4 branches. These branches are Group 1: Waiting 1 Minute After Paracervical Block, Group 2: Waiting 3 Minute After Paracervical Block, Group 3: Control Group and Group 4: Waiting 60 Minute After Taking Oral NSAIDs. Thirty patients will be included in each group using power analysis of clinical studies in which endometrial biopsy techniques and pain comparisons were performed before [Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018;132(3):575-582.].
Pregnancy, pelvic infections, heavy bleeding disorders and NSAID allergy are the exclusion criteria.
In the study, the success of analgesic methods to be used for endometrial biopsy during and 30 minutes after the procedure will be compared. These methods include waiting 1 minute after the paracervical block is performed, waiting 3 minutes after the paracervical block is performed, and taking oral NSAIDs one hour before the procedure. All arms will be included 30 participants and control group with 30 participants is formed. The Numeric Pain Rating Scale (NPRS) system will be used for each case for pain during the procedure and 30 minutes after the procedure. According to this system, the fact that the participant have no pain will be evaluated as "0" point and having the most severe pain she can experience is "10" points.
Before procedure the cervix and vaginal vault will be prepared with povidone iodine. A vaginal speculum will be used for optimal exposure and manipulation of cervix. All procedures will be performed without grasping the cervix with a tenaculum. Two-point (at 4 and 8 o'clock only) technique will be used for paracervical block for Group 1: Waiting 1 Minute After Paracervical Block and Group 2: Waiting 3 Minute After Paracervical Block. For these groups 10 ml 2% Prilocaine (VEM İlac, Tekirdag, Turkey) will be injected for each side approximately 10 mm into the cervical stroma at the cervico-vaginal junction with a 22- gauge hypodermic needle. The capped needle model will be employed for Group 3: Control Group. After cervical and vaginal preparation with povidone iodine a capped needle will be touched the cervico-vaginal junction at 4 and 8 o'clock. 550 mg Naproxen Sodium (Abdi Ibrahim, Turkey) will be given to participants in the Group 4, 60 minutes before the procedure.
For all procedures, low pressure sampling device (Pipelle Cannula, Medbar Medical Equipment Inc.)will be inserted to the cavity and endometrial samples will be obtained using a corkscrew rotation combined with a repeating cephalic-caudal motion. The procedure will be repeated twice in each case to ensure standardization. All endometrial biopsies will be performed by the same operator.
NPRS system will be explained to all groups after the procedure and the pain during the procedure will be requested to be graded. Thirty minutes after the procedure, the participants will be asked to rate current pain according to the NPRS system.
The study was approved by institutional ethics committee. Written informed consent will be obtained from all participants.
- Being tested
- Paracervical Block, 550 mg Naproxen Sodium 60 minutes before the procedure, The capped needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracervical BlockProcedure or surgery
Also called 550 mg Naproxen Sodium 60 minutes before the procedure.
Two-point (at 4 and 8 o'clock only) technique will be used for paracervical block for Group 1: Waiting 1 Minute After Paracervical Block and Group 2: Waiting 3 Minute After Paracervical Block. For these groups 10 ml 2% Prilocaine (VEM İlac, Tekirdag, Turkey) will be injected for each side approximately 10 mm into the cervical stroma at the cervico-vaginal junction with a 22- gauge hypodermic needle.
550 mg Naproxen Sodium 60 minutes before the procedureDrug
550 mg Naproxen Sodium (Abdi Ibrahim, Turkey) will be given to participants in the Group 4, 60 minutes before the procedure.
The capped needleProcedure or surgery
The capped needle model will be employed for Group 3: Control Group. After cervical and vaginal preparation with povidone iodine a capped needle will be touched the cervico-vaginal junction at 4 and 8 o'clock.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Waiting 1 Minute After Paracervical Block | Active comparator | Not described Receives: Procedure: Paracervical Block |
| Group 2: Waiting 3 Minute After Paracervical Block | Active comparator | Not described Receives: Procedure: Paracervical Block |
| Group 3: Control Group | Placebo comparator | Not described Receives: Procedure: The capped needle |
| Group 4: Waiting 60 Minute After Taking Oral NSAIDs | Active comparator | Not described Receives: Drug: 550 mg Naproxen Sodium 60 minutes before the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numeric Pain Rating Scale 0
The Numeric Pain Rating Scale (NPRS) system will be used for each case for pain during the procedure. According to this system, the fact that the participant has no pain is evaluated as "0" point and having the most severe pain she could experience is "10" points.
Measured: Baseline (0 minute)
The Numeric Pain Rating Scale 30
The Numeric Pain Rating Scale (NPRS) system will be used for each case for pain 30 minutes after procedure. According to this system, the fact that the participant has no pain is evaluated as "0" point and having the most severe pain she could experience is "10" points.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start28 Sep 2020
- Primary completion3 Nov 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Office-based Endometrial Sampling ProceduresStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Anıl Arı, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572828
- Sponsor's protocol ID
- 20-6.1T/67
- Status last verified
- Nov 2021
- First submitted
- 28 Sep 2020
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Paracervical Block in Endometrial Sampling Procedures for Pain Control: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04572828
- Acronym / sponsor ID
- 20-6.1T/67
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 1 Oct 2020 (actual)
- 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.
Office-based endometrial procedures are preferred over diagnostic dilation and curettage, nowadays. Paracervical block is single-shot nerve block that involve a one-time injection of local anesthetic adjacent to the utero-vaginal nerve plexus. Block provides analgesia during cervical pass of sampling device or manipulation of cervix. The paracervical block seems to work within few minutes after injection, but the optimal waiting time between injection and procedure is not known. In this randomized controlled study, it was aimed to determine the effect of waiting time of 1 minute and 3 minutes after paracervical block in endometrial sampling procedures using Pipelle cannula in terms of pain during and after the endometrial sampling and to compare with NSAIDs taken before the procedure.
Detailed description
120 participants who will undergo endometrial biopsy due to abnormal uterine bleeding will be enrolled in the study. The research will be conducted in 4 branches. These branches are Group 1: Waiting 1 Minute After Paracervical Block, Group 2: Waiting 3 Minute After Paracervical Block, Group 3: Control Group and Group 4: Waiting 60 Minute After Taking Oral NSAIDs. Thirty patients will be included in each group using power analysis of clinical studies in which endometrial biopsy techniques and pain comparisons were performed before [Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018;132(3):575-582.].
Pregnancy, pelvic infections, heavy bleeding disorders and NSAID allergy are the exclusion criteria.
In the study, the success of analgesic methods to be used for endometrial biopsy during and 30 minutes after the procedure will be compared. These methods include waiting 1 minute after the paracervical block is performed, waiting 3 minutes after the paracervical block is performed, and taking oral NSAIDs one hour before the procedure. All arms will be included 30 participants and control group with 30 participants is formed. The Numeric Pain Rating Scale (NPRS) system will be used for each case for pain during the procedure and 30 minutes after the procedure. According to this system, the fact that the participant have no pain will be evaluated as "0" point and having the most severe pain she can experience is "10" points.
Before procedure the cervix and vaginal vault will be prepared with povidone iodine. A vaginal speculum will be used for optimal exposure and manipulation of cervix. All procedures will be performed without grasping the cervix with a tenaculum. Two-point (at 4 and 8 o'clock only) technique will be used for paracervical block for Group 1: Waiting 1 Minute After Paracervical Block and Group 2: Waiting 3 Minute After Paracervical Block. For these groups 10 ml 2% Prilocaine (VEM İlac, Tekirdag, Turkey) will be injected for each side approximately 10 mm into the cervical stroma at the cervico-vaginal junction with a 22- gauge hypodermic needle. The capped needle model will be employed for Group 3: Control Group. After cervical and vaginal preparation with povidone iodine a capped needle will be touched the cervico-vaginal junction at 4 and 8 o'clock. 550 mg Naproxen Sodium (Abdi Ibrahim, Turkey) will be given to participants in the Group 4, 60 minutes before the procedure.
For all procedures, low pressure sampling device (Pipelle Cannula, Medbar Medical Equipment Inc.)will be inserted to the cavity and endometrial samples will be obtained using a corkscrew rotation combined with a repeating cephalic-caudal motion. The procedure will be repeated twice in each case to ensure standardization. All endometrial biopsies will be performed by the same operator.
NPRS system will be explained to all groups after the procedure and the pain during the procedure will be requested to be graded. Thirty minutes after the procedure, the participants will be asked to rate current pain according to the NPRS system.
The study was approved by institutional ethics committee. Written informed consent will be obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Waiting 1 Minute After Paracervical Block | Active comparator | Procedure: Paracervical Block |
| Group 2: Waiting 3 Minute After Paracervical Block | Active comparator | Procedure: Paracervical Block |
| Group 3: Control Group | Placebo comparator | Procedure: The capped needle |
| Group 4: Waiting 60 Minute After Taking Oral NSAIDs | Active comparator | Drug: 550 mg Naproxen Sodium 60 minutes before the procedure |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Abnormal uterine bleeding
Key exclusion criteria (4 listed)
- Pregnancy
- Pelvic infections
- Heavy bleeding disorders
- NSAID allergy
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 |
|---|---|---|
| Paracervical BlockAlso: 550 mg Naproxen Sodium 60 minutes before the procedure.Two-point (at 4 and 8 o'clock only) technique will be used for paracervical block for Group 1: Waiting 1 Minute After Paracervical Block and Group 2: Waiting 3 Minute After Paracervical Block. For these groups 10 ml 2% Prilocaine (VEM İlac, Tekirdag, Turkey) will be injected for each side approximately 10 mm into the cervical stroma at the cervico-vaginal junction with a 22- gauge hypodermic needle. | Procedure or surgery | Group 1: Waiting 1 Minute After Paracervical Block, Group 2: Waiting 3 Minute After Paracervical Block |
| 550 mg Naproxen Sodium 60 minutes before the procedure550 mg Naproxen Sodium (Abdi Ibrahim, Turkey) will be given to participants in the Group 4, 60 minutes before the procedure. | Drug | Group 4: Waiting 60 Minute After Taking Oral NSAIDs |
| The capped needleThe capped needle model will be employed for Group 3: Control Group. After cervical and vaginal preparation with povidone iodine a capped needle will be touched the cervico-vaginal junction at 4 and 8 o'clock. | Procedure or surgery | Group 3: Control Group |
Primary outcome
The Numeric Pain Rating Scale 0
Time frame: Baseline (0 minute)
The Numeric Pain Rating Scale (NPRS) system will be used for each case for pain during the procedure. According to this system, the fact that the participant has no pain is evaluated as "0" point and having the most severe pain she could experience is "10" points.
The Numeric Pain Rating Scale 30
Time frame: 30 minutes
The Numeric Pain Rating Scale (NPRS) system will be used for each case for pain 30 minutes after procedure. According to this system, the fact that the participant has no pain is evaluated as "0" point and having the most severe pain she could experience is "10" points.
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 19 Nov 2021.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracervical Block, 550 mg Naproxen Sodium 60 minutes before the procedure and The capped needle in people with Office-based Endometrial Sampling Procedures, run by Ege University at 1 site in Turkey (Türkiye).
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 4 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 19 Nov 2021. 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 Turkey (Türkiye). 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.
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?
The Numeric Pain Rating Scale 0 (time frame: Baseline (0 minute)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2021.