Pain ScoreNCT02007408
Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial
A study testing Paracervical block, Lidocaine spray and Paracervical block + lidocaine spray in people with Pain Score, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: The investigators sought to investigate the analgesic efficiency of lidocaine spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray combination in patients undergoing first-trimester surgical abortion. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Score
- What is being tested?
- Paracervical block, Lidocaine spray and Paracervical block + lidocaine spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2013to Aug 2013
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >18 years Single Pregnancy <7 weeks of gestation
Who cannot join
- Incomplete abortion Early pregnancy failure Acute cervicitis Untreated pelvic inflammatory disease Cervical stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Objective: The investigators sought to investigate the analgesic efficiency of lidocaine spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray combination in patients undergoing first-trimester surgical abortion.
Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108 women with the request of pregnancy termination.The subjects were randomly assigned into four groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard Visual Analog Scale (VAS).
- Conditions
- Pain Score
- Being tested
- Paracervical block, Lidocaine spray, Paracervical block + lidocaine spray
- Keywords
- abortion, analgesia, paracervical block, lidocaine spray
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracervical blockDrug
Lidocaine sprayDrug
Paracervical block + lidocaine sprayDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described |
| Paracervical block plus lidocaine spray | Active comparator | Lidocaine injection+Lidocaine spray received PCB with 2 ampoules of lidocaine solution plus 2 pumps (20 mg=2 pumps) of 10% lidocaine spray Receives: Drug: Paracervical block + lidocaine spray |
| paracervical block plus isotonic saline spray | Active comparator | 2 ampoules of lidocaine solution (20 mg Lidocaine HCl+0.0125 mg epinephrine/ml) plus isotonic spray Receives: Drug: Paracervical block |
| only lidocaine spray | Active comparator | paracervical block with saline solution plus 10% lidocaine spray Receives: Drug: Lidocaine spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analog Scale
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ScoreStudies 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, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gökhan Açmaz, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007408
- Sponsor's protocol ID
- KERH
- Status last verified
- Dec 2013
- First submitted
- 25 Nov 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02007408
- Acronym / sponsor ID
- KERH
- Conditions
- Pain Score
- Keywords
- abortion, analgesia, paracervical block, lidocaine spray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Dec 2013 (estimated)
- 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.
Objective: The investigators sought to investigate the analgesic efficiency of lidocaine spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray combination in patients undergoing first-trimester surgical abortion.
Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108 women with the request of pregnancy termination.The subjects were randomly assigned into four groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard Visual Analog Scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | – |
| Paracervical block plus lidocaine spray | Active comparator | Drug: Paracervical block + lidocaine sprayLidocaine injection+Lidocaine spray received PCB with 2 ampoules of lidocaine solution plus 2 pumps (20 mg=2 pumps) of 10% lidocaine spray |
| paracervical block plus isotonic saline spray | Active comparator | Drug: Paracervical block2 ampoules of lidocaine solution (20 mg Lidocaine HCl+0.0125 mg epinephrine/ml) plus isotonic spray |
| only lidocaine spray | Active comparator | Drug: Lidocaine sprayparacervical block with saline solution plus 10% lidocaine spray |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age >18 years Single Pregnancy <7 weeks of gestation
Key exclusion criteria (1 listed)
- Incomplete abortion Early pregnancy failure Acute cervicitis Untreated pelvic inflammatory disease Cervical stenosis
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 block | Drug | paracervical block plus isotonic saline spray |
| Lidocaine spray | Drug | only lidocaine spray |
| Paracervical block + lidocaine spray | Drug | Paracervical block plus lidocaine spray |
Primary outcome
Pain Scores on the Visual Analog Scale
Time frame: Three months
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 10 Dec 2013.
Related trials for Pain Score
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
RecruitingPhase 4
Comparing Intravitreal Injection Pain Scores Using Iheezo (Chloroprocaine Hcl Ophthalmic Gel 3%) Versus Subconjunctival Lidocaine (2%): A Randomized, Controlled Trial
No Condition
Recruiting
Acupressure as Complementary Analgesia in Shock Wave Lithotripsy
Acupressure, Urinary Calculi
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
Not yet recruiting
Quadro-Iliac Plane Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia Repair
Inguinal Hernia Unilateral, Postoperative Pain
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, Lidocaine spray and Paracervical block + lidocaine spray in people with Pain Score, run by Kayseri Education and Research Hospital 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 1 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 10 Dec 2013. 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?
Pain Scores on the Visual Analog Scale (time frame: Three months). 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 10 Dec 2013.