Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage
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|ClinicalTrials.gov Identifier: NCT03736681|
Recruitment Status : Active, not recruiting
First Posted : November 9, 2018
Last Update Posted : March 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Abortion Early Abortion, Missed Abortion, Spontaneous Abortion in First Trimester||Drug: 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block Drug: 20cc 1% lidocaine with 2 units of vasopressin paracervical block||Phase 1|
Dilation and Curettage (D&C) is often performed in the first trimester for surgical abortion and management of miscarriage and can be painful for patients before and after the procedure. Most procedures are performed while the patient is awake or with minimal sedation in the clinic setting, and a key component of pain control is the paracervical block, or injecting lidocaine into the tissue around the cervix. A paracervical block with 20cc of 1% buffered lidocaine has been proven to provide superior pain control than a sham paracervical block. However, many providers often use similar doses of lidocaine in a higher volume to improve pain control. At University of California, San Diego (UCSD) and University of California, Los Angeles (UCLA), some providers routinely use a 20cc of 1% buffered lidocaine block and some routinely use a 40cc of 0.5% buffered lidocaine block. This practice has not been studied in a randomized controlled trial. The purpose of this study is to compare pain control during D&C with a 20cc 1% buffered lidocaine with vasopressin paracervical block compared to a 40cc 0.5% buffered lidocaine with vasopressin paracervical block.
An inclusion criterion for this study is that patients must specifically be referred to family planning clinics at UCSD and UCLA for an in-clinic D&C. Therefore, the D&C is a required procedure for both study groups. The only difference in care between the study groups will be which paracervical block they receive.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a double center, randomized, 2-arm (1:1), single blinded clinical trial comparing pain control at the time of cervical dilation with two different paracervical blocks in women undergoing D&C in the first trimester for either surgical abortion or miscarriage management.|
|Official Title:||Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial|
|Actual Study Start Date :||October 29, 2018|
|Actual Primary Completion Date :||December 14, 2020|
|Estimated Study Completion Date :||July 1, 2021|
40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
Drug: 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block
Women undergoing D&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
Active Comparator: 20cc
20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
Drug: 20cc 1% lidocaine with 2 units of vasopressin paracervical block
Women undergoing D&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
- Pain during cervical dilation [ Time Frame: immediate ]Distance (mm) from the left of the 100-mm Visual Analogue Scale (VAS) scale (reflecting magnitude of pain) recorded at time of cervical dilation. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable. We will also assess pain at various time points (including secondary outcomes) immediately upon completion of the respective step.
- Pain level at other time points (baseline, speculum placement, block placement, uterine aspiration, 10 minutes post-procedure, overall) [ Time Frame: during 1 day of clinic visit ]pain at different time points
- Patient Satisfaction [ Time Frame: during 1 day of clinic visit ]How did the paint compare to the expected pain? What could have been better?
- Adverse events [ Time Frame: immediate ]side effects at time of paracervical block placement
- Survey of provider performing procedure [ Time Frame: during 1 day of clinic visit ]Clinical questions about the patient and the procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736681
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Sheila K Mody, MD MPH||UCSD Department of Ob/Gyn and Reproductive Sciences|