Abortion, InducedNCT00816751
Paracervical Versus Intracervical Lidocaine
A study testing Paracervical block, Intracervical and Buffered Lidocaine, vasopressin, sodium bicarbonate in people with Abortion, Induced and Pain, run by University of California, San Diego at 1 site in United States.
Trial summary
The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Induced, Pain
- What is being tested?
- Paracervical block, Intracervical and Buffered Lidocaine, vasopressin, sodium bicarbonate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Feb 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women presenting for elective first trimester abortion
Who cannot join
- Gestation over 12 weeks by ultrasound
- Weight less than 98 pounds
- Known allergy to lidocaine
- Known nonviable pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paracervical Versus Intracervical Lidocaine for Suction Curettage: A Randomized Controlled Trial
The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical block would produce lower pain scores than paracervical block at the time of cervical dilation.
- Conditions
- Abortion, Induced, Pain
- Being tested
- Paracervical block, Intracervical, Buffered Lidocaine, vasopressin, sodium bicarbonate
- Keywords
- Local anesthesia, Paracervical, Intracervical, Abortion, Pain, Local anesthesia for elective first trimester abortion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracervical blockProcedure or surgery
The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.
IntracervicalProcedure or surgery
The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.
Buffered Lidocaine, vasopressin, sodium bicarbonateDrug
The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Paracervical block; Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate |
| 2 | Experimental | Not described Receives: Procedure: Intracervical; Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)
VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain
Measured: at completion of procedure
Secondary outcomes (1)
Gestational Age at Time of Procedure
Measured: At the time of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startDec 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abortion, InducedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Kingston, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816751
- Sponsor's protocol ID
- ONG-08-1781
- Status last verified
- Jul 2019
- First submitted
- 31 Dec 2008
- Last updated
- 13 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracervical Versus Intracervical Lidocaine for Suction Curettage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00816751
- Acronym / sponsor ID
- ONG-08-1781
- Conditions
- Abortion, Induced, Pain
- Keywords
- Local anesthesia, Paracervical, Intracervical, Abortion, Pain, Local anesthesia for elective first trimester abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Jan 2009 (estimated)
- Results
- Posted 13 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical block would produce lower pain scores than paracervical block at the time of cervical dilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Paracervical block, Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate |
| 2 | Experimental | Procedure: Intracervical, Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women presenting for elective first trimester abortion
Key exclusion criteria (4 listed)
- Gestation over 12 weeks by ultrasound
- Weight less than 98 pounds
- Known allergy to lidocaine
- Known nonviable pregnancy
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 blockThe paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub. | Procedure or surgery | 1 |
| IntracervicalThe intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub. | Procedure or surgery | 2 |
| Buffered Lidocaine, vasopressin, sodium bicarbonateThe buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate. | Drug | 1, 2 |
Primary outcome
Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)
Time frame: at completion of procedure
VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain
1 secondary outcome
Gestational Age at Time of Procedure
Time frame: At the time of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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, Intracervical and Buffered Lidocaine, vasopressin, sodium bicarbonate in people with Abortion, Induced and Pain, run by University of California, San Diego at 1 site in United States.
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 13 Aug 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 States. 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. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS) (time frame: at completion of procedure). 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 13 Aug 2019.