PainPhase 2/3NCT00617097
Paracervical Block in First Trimester Surgical Abortions
A Phase 2/3 study testing lidocaine and ketorolac and lidocaine in people with Pain and Surgical Abortion, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Surgical Abortion
- What is being tested?
- lidocaine and ketorolac and lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2009
- Phase
- Phase 2/3
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age greater than or equal to 18 years
- English-speaking
- ability and willingness to sign the informed consent
- ability and willingness to comply with the terms of the study
- voluntary request for pregnancy termination
- ultrasound-confirmed singleton intrauterine pregnancy with an estimated gestational age not exceeding 76 days (10 6/7 weeks) from the first day of the preceding menstrual cycle
Who cannot join
- women who require or request sedation
- untreated acute cervicitis or pelvic inflammatory disease
- contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria
- allergic reaction or sensitivity to lorazepam or NSAIDs
- chronic NSAID use
- history of gastritis or gastric ulcer
Show all 11Show fewer
- acute renal failure or chronic renal disease
- chronic liver disease
- history of bleeding diathesis
- chronic narcotic use
- current or past history of illegal drug use (excluding marijuana)
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Columbia-Willamette
Portland, Oregon, 97239
About this study
Official title: Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions
The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize that women who receive a paracervical block of combined ketorolac and lidocaine will experience less pain during the procedure based on a visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a paracervical block with lidocaine alone.
This randomized, multi-site, placebo-controlled clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical block with lidocaine alone. A total of fifty women who are seeking elective surgical abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore, Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during, and after surgical abortion will be measured using a 100-mm VAS.
The primary outcome of interest is the mean difference in pain level from preoperative baseline to time after cervical dilation comparing the treatment groups. If the investigators see greater pain reduction associated with the paracervical block of lidocaine and ketorolac, adoption of this regimen may improve pain management during first trimester surgical abortions. If combined ketorolac and lidocaine when administered as a paracervical block is proven to be efficacious, the need for additional analgesia in first trimester surgical abortions can be minimized.
- Conditions
- Pain, Surgical Abortion
- Being tested
- lidocaine, ketorolac and lidocaine
- Keywords
- Pain associated with first trimester surgical abortion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
paracervical block with lidocaine
ketorolac and lidocaineDrug
paracervical block with ketorolac and lidocaine
| Study group | Role | What they receive |
|---|---|---|
| paracervical block with lidocaine | Active comparator | Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion Receives: Drug: lidocaine |
| paracervical block with ketorolac and lidocaine | Experimental | Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion Receives: Drug: ketorolac and lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
100-mm Visual Analogue Scale (VAS) during specific time intervals of D\&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain)
Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure.
Measured: Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure
Secondary outcomes (3)
Visual Analogue Scale Regarding Satisfaction Level
100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)
Measured: end of study (prior to clinic discharge)
Reported Symptoms
fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)
Measured: end of study (upon discharge from facility after procedure)
Complications
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2009
- Study completionJun 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Johns Hopkins University, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617097
- Sponsor's protocol ID
- NA_00013075
- Other IDs
- SFP1-1
- Status last verified
- Aug 2017
- First submitted
- 28 Dec 2007
- Last updated
- 15 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cansino C, Edelman A, Burke A, Jamshidi R. Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1220-1226. doi: 10.1097/AOG.0b013e3181c1a55b.
PubMed 19935022
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions
- ClinicalTrials.gov ID
- NCT00617097
- Acronym / sponsor ID
- NA_00013075
- Conditions
- Pain, Surgical Abortion
- Keywords
- Pain associated with first trimester surgical abortion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- Jan 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize that women who receive a paracervical block of combined ketorolac and lidocaine will experience less pain during the procedure based on a visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a paracervical block with lidocaine alone.
This randomized, multi-site, placebo-controlled clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical block with lidocaine alone. A total of fifty women who are seeking elective surgical abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore, Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during, and after surgical abortion will be measured using a 100-mm VAS.
The primary outcome of interest is the mean difference in pain level from preoperative baseline to time after cervical dilation comparing the treatment groups. If the investigators see greater pain reduction associated with the paracervical block of lidocaine and ketorolac, adoption of this regimen may improve pain management during first trimester surgical abortions. If combined ketorolac and lidocaine when administered as a paracervical block is proven to be efficacious, the need for additional analgesia in first trimester surgical abortions can be minimized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paracervical block with lidocaine | Active comparator | Drug: lidocaineSubjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion |
| paracervical block with ketorolac and lidocaine | Experimental | Drug: ketorolac and lidocaineSubjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age greater than or equal to 18 years
- English-speaking
- ability and willingness to sign the informed consent
- ability and willingness to comply with the terms of the study
- voluntary request for pregnancy termination
Key exclusion criteria (11 listed)
- women who require or request sedation
- untreated acute cervicitis or pelvic inflammatory disease
- contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria
- allergic reaction or sensitivity to lorazepam or NSAIDs
- chronic NSAID use
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 |
|---|---|---|
| lidocaineparacervical block with lidocaine | Drug | paracervical block with lidocaine |
| ketorolac and lidocaineparacervical block with ketorolac and lidocaine | Drug | paracervical block with ketorolac and lidocaine |
Primary outcome
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
Time frame: Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure
100-mm Visual Analogue Scale (VAS) during specific time intervals of D\&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain) Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure.
3 secondary outcomes
Visual Analogue Scale Regarding Satisfaction Level
Time frame: end of study (prior to clinic discharge)
Reported Symptoms
Time frame: end of study (upon discharge from facility after procedure)
Complications
Time frame: end of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19935022Cansino C, Edelman A, Burke A, Jamshidi R. Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1220-1226. doi: 10.1097/AOG.0b013e3181c1a55b.
Related trials for Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
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.
Johns Hopkins University, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing lidocaine and ketorolac and lidocaine in people with Pain and Surgical Abortion, run by Johns Hopkins University 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 6 inclusion and 11 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 15 Sep 2017. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2014). 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?
Level of Pain During Specific Time Intervals Throughout D&C Procedure. (time frame: Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00617097, which also lists 1 linked publication.
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 15 Sep 2017.