Buffered Lidocaine in Paracervical Blocks
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 14 - Any |
| Updated: | 5/4/2018 |
| Start Date: | May 15, 2017 |
| End Date: | March 2019 |
| Contact: | Principal Investigator |
| Email: | WHRC@hawaii.edu |
| Phone: | (808) 203-6500 |
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain During First Trimester Uterine Aspirations
For pain relief during a first trimester surgical aspiration, most providers use the
paracervical block, either alone or in combination with other pain control techniques. Some
providers use buffered lidocaine due to a belief that it decreases pain. Others use plain
lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain
lidocaine in a two site injection. Few studies have compared buffered versus unbuffered
lidocaine for paracervical blocks during first trimester uterine aspirations. This study
seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for
paracervical blocks.
paracervical block, either alone or in combination with other pain control techniques. Some
providers use buffered lidocaine due to a belief that it decreases pain. Others use plain
lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain
lidocaine in a two site injection. Few studies have compared buffered versus unbuffered
lidocaine for paracervical blocks during first trimester uterine aspirations. This study
seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for
paracervical blocks.
Potential participants will be identified at their office visits to the University Women's
Health Specialists. If a patient desires uterine aspiration of a first trimester pregnancy or
management of a failed pregnancy in the first trimester, they will first receive standard
counseling. Only after providing written informed consent for the procedure will the
patient's be screened for eligibility for our study. If the patient is eligible, she will be
asked by a member of the research team if she is interested in participating. If she is, the
study will be explained to her and written consent will be obtained after she is given the
opportunity to have all of her questions answered. The patient will then complete a written
questionnaire to collect demographic data.
This prospective randomized control trial will consist of two study arms. Participants will
be randomly assigned to Arm 1, where a paracervical block will be administered with 20 cc of
1% lidocaine, which is our standard office protocol, or to Arm 2, where a paracervical block
will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate. Prior
to the start of the study, study assignments will be generated in a 1:1 ratio.
All patients who consent to the study will receive standard counseling prior to their
procedure. The procedure will start with a bimanual exam by the provider. Next, the provider
will place a speculum, cleanse the cervix with betadine solution, and place a single-tooth
tenaculum on the anterior lip of the cervix. At this point, participants assigned to Arm 1
will receive a paracervical block loaded with 20 cc of 1% lidocaine and injected at 2, 4, 8
and 10 o'clock positions of the cervicovaginal junction. Participants assigned to Arm 2 will
receive a paracervical block loaded with 18 cc of 1% lidocaine and 2 cc of 8.4% sodium
bicarbonate and inject the block in the same fashion. The research assistant will ask the
patient to verbally report their level of pain based on the 100 mm visual analog scale (VAS)
at the following points of the procedure:
1. Prior to the start of the procedure (baseline anxiety)
2. After speculum placement
3. After paracervical block
4. After cervical dilation
5. After suction curettage
6. At end of procedure
Health Specialists. If a patient desires uterine aspiration of a first trimester pregnancy or
management of a failed pregnancy in the first trimester, they will first receive standard
counseling. Only after providing written informed consent for the procedure will the
patient's be screened for eligibility for our study. If the patient is eligible, she will be
asked by a member of the research team if she is interested in participating. If she is, the
study will be explained to her and written consent will be obtained after she is given the
opportunity to have all of her questions answered. The patient will then complete a written
questionnaire to collect demographic data.
This prospective randomized control trial will consist of two study arms. Participants will
be randomly assigned to Arm 1, where a paracervical block will be administered with 20 cc of
1% lidocaine, which is our standard office protocol, or to Arm 2, where a paracervical block
will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate. Prior
to the start of the study, study assignments will be generated in a 1:1 ratio.
All patients who consent to the study will receive standard counseling prior to their
procedure. The procedure will start with a bimanual exam by the provider. Next, the provider
will place a speculum, cleanse the cervix with betadine solution, and place a single-tooth
tenaculum on the anterior lip of the cervix. At this point, participants assigned to Arm 1
will receive a paracervical block loaded with 20 cc of 1% lidocaine and injected at 2, 4, 8
and 10 o'clock positions of the cervicovaginal junction. Participants assigned to Arm 2 will
receive a paracervical block loaded with 18 cc of 1% lidocaine and 2 cc of 8.4% sodium
bicarbonate and inject the block in the same fashion. The research assistant will ask the
patient to verbally report their level of pain based on the 100 mm visual analog scale (VAS)
at the following points of the procedure:
1. Prior to the start of the procedure (baseline anxiety)
2. After speculum placement
3. After paracervical block
4. After cervical dilation
5. After suction curettage
6. At end of procedure
Inclusion Criteria:
- Pregnant women 14 years and older
- Desiring uterine aspiration for pregnancy or surgical management of a miscarriage
- Gestational age up to 13 weeks and 6 days to be established by best dating (i.e. last
menstrual period [LMP] or earliest ultrasound)
- Treatment plan involves outpatient uterine aspiration
- Participant able to provide informed consent in English and willing to participate in
the study
Exclusion Criteria:
- Unable to read, speak, or understand English
- Unable to provide informed consent
- Currently incarcerated
- Under the age of 14 years
- Contraindications to receiving lidocaine or buffered lidocaine
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