Effect of DrugPhase 4NCT06539143
Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration
A Phase 4 study testing Lidocaine in people with Effect of Drug, run by Darlington-Peter Chibuzor Ugoji at 1 site in Nigeria.
Trial summary
Miscarriage is one of the major causes of early pregnancy losses. Incomplete miscarriage is a major cause of maternal morbidity and mortality. Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage. 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
- Effect of Drug
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteNigeria
- Study dates
- 27 Jun 2023to 26 Sep 2023
- Phase
- Phase 4
- 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
- - Between the ages of 18- 45 years.
- Spontaneous incomplete miscarriage at less than 13 weeks.
- Not allergic to drugs for the study
- Patients that give consent
Who cannot join
- - Patients who do not consent to MVA [ Manual vacuum aspiration].
- Those with known allergy history to the drug agents.
- Those with septic incomplete miscarriage.
- Patients with infection at the cervical blocking sites.
- Those with active pelvic inflammatory disease.
- Patients with neurological or psychiatric disease.
- Incomplete miscarriage at greater than 13 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration for First Trimester Incomplete Miscarriage in Abakaliki: A Randomized Trial
Miscarriage is one of the major causes of early pregnancy losses. Incomplete miscarriage is a major cause of maternal morbidity and mortality. Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage. The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital, Abakaliki [AEFUTHA].
Read the detailed description
SUMMARY
Background:
First trimester pregnancy losses are estimated to occur in 14-19% of all clinically confirmed pregnancies and account for about 80% of all the pregnancy losses. Miscarriage is one of the major causes of early pregnancy losses. Incomplete miscarriage is a major cause of maternal morbidity and mortality.
Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage. In my center, conscious sedation is mostly used but because of the pronounced systemic side effect of drowsiness, weakness etc, there is a shift to paracervical block hence this study.
Objectives:
The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital, Abakaliki [AEFUTHA].
Methodology:
This was a randomized control trial equivalent study that compared the analgesia from conscious sedation with that of the paracervical block in women selected for manual vacuum aspiration following first trimester incomplete miscarriage in AEFUTHA. Patients were categorized into groups: A and B. Those in group A received conscious sedation using intravenous diazepam 10 mg and intravenous pentazocine 30 mg stat while those in the other group B received paracervical block via the use of 10ml of 1% lidocaine with 4ml at 4:00 clock and 8:00 clock respectively and 2ml at the anterior lip of the cervix. After analgesic effect has occurred, manual vacuum aspiration was done and there after pain assessment was be carried out at 10 mins, 2 hours, 6 hours, 12 hours and 24 hours respectively. The vital signs and oxygen saturation pre and post operatively were monitored with chart kept for analysis.
Analysis:
The data were analyzed using Spss, version 28.0 (2022). Continuous variables were compared with t- test while categorical variables were compared with Chi- square and the p-value determined. P- value less than 0.05 was taken to be statistically significant.
- Conditions
- Effect of Drug
- Being tested
- Lidocaine
- Keywords
- miscarriage, analgesia, manual vacuum aspiration
- Medical subject headings
- Abortion, Spontaneous, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine
The Paracervical Block with lidocaine for manual vacuum aspiration
| Study group | Role | What they receive |
|---|---|---|
| GROUP A (Conscious Sedation) | Active comparator | 30mg of pentazocine was given intravenously, over one minute and a latency period of about 2 minutes was allowed before starting the procedure for analgesic function to take effect. Receives: Drug: Lidocaine |
| GROUP B (The Paracervical Block) | Experimental | Received 10 ml of 1% lidocaine, for the blocks with 4ml at 4 O' clock and 8 O'clock positions and 2 ml at the anterior cervical lip. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score using the Visual analogue scale
The primary outcome measure is the mean pain score of the participants in the study groups.
Measured: Pain and side effects experienced following the use of the analgesic agents at about 10 minutes, 2 hours, 6 hours, 12 hours and 24 hours following the procedure was noted. Higher score showed more pain and lower score showed lower pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start27 Jun 2023
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of DrugStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a clinical equivalence randomized controlled trial comparing the efficacy of conscious sedation and paracervical block among women selected for manual vacuum aspiration following incomplete miscarriages in first trimester in Alex Ekwueme Federal University Teaching Hospital, Abakaliki (AEFUTHA), Ebonyi State.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darlington-Peter Chibuzor Ugoji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Darlington-Peter Chibuzor Ugoji, Alex Ekwueme Federal University Teaching Hospital
- Investigators
- DARLINTON-PETER CHIBUZOR C UGOJI, MBBS, Principal investigator, Alex Ekwueme Federal University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539143
- Sponsor's protocol ID
- NHREC/16/05/22/209
- Status last verified
- Aug 2024
- First submitted
- 14 Apr 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This will only be after full defense of the work at the college
Publications
Sotiriadis A, Makrydimas G, Papatheodorou S, Ioannidis JP. Expectant, medical, or surgical management of first-trimester miscarriage: a meta-analysis. Obstet Gynecol. 2005 May;105(5 Pt 1):1104-13. doi: 10.1097/01.AOG.0000158857.44046.a4.
PubMed 15863551
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration for First Trimester Incomplete Miscarriage in Abakaliki: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06539143
- Acronym / sponsor ID
- NHREC/16/05/22/209
- Conditions
- Effect of Drug
- Keywords
- miscarriage, analgesia, manual vacuum aspiration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Darlington-Peter Chibuzor UgojiUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 6 Aug 2024 (actual)
- 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.
Miscarriage is one of the major causes of early pregnancy losses. Incomplete miscarriage is a major cause of maternal morbidity and mortality. Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage. The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital, Abakaliki [AEFUTHA].
Detailed description
SUMMARY
Background:
First trimester pregnancy losses are estimated to occur in 14-19% of all clinically confirmed pregnancies and account for about 80% of all the pregnancy losses. Miscarriage is one of the major causes of early pregnancy losses. Incomplete miscarriage is a major cause of maternal morbidity and mortality.
Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage. In my center, conscious sedation is mostly used but because of the pronounced systemic side effect of drowsiness, weakness etc, there is a shift to paracervical block hence this study.
Objectives:
The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital, Abakaliki [AEFUTHA].
Methodology:
This was a randomized control trial equivalent study that compared the analgesia from conscious sedation with that of the paracervical block in women selected for manual vacuum aspiration following first trimester incomplete miscarriage in AEFUTHA. Patients were categorized into groups: A and B. Those in group A received conscious sedation using intravenous diazepam 10 mg and intravenous pentazocine 30 mg stat while those in the other group B received paracervical block via the use of 10ml of 1% lidocaine with 4ml at 4:00 clock and 8:00 clock respectively and 2ml at the anterior lip of the cervix. After analgesic effect has occurred, manual vacuum aspiration was done and there after pain assessment was be carried out at 10 mins, 2 hours, 6 hours, 12 hours and 24 hours respectively. The vital signs and oxygen saturation pre and post operatively were monitored with chart kept for analysis.
Analysis:
The data were analyzed using Spss, version 28.0 (2022). Continuous variables were compared with t- test while categorical variables were compared with Chi- square and the p-value determined. P- value less than 0.05 was taken to be statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a clinical equivalence randomized controlled trial comparing the efficacy of conscious sedation and paracervical block among women selected for manual vacuum aspiration following incomplete miscarriages in first trimester in Alex Ekwueme Federal University Teaching Hospital, Abakaliki (AEFUTHA), Ebonyi State.
| Arm | Type | Receives |
|---|---|---|
| GROUP A (Conscious Sedation) | Active comparator | Drug: Lidocaine30mg of pentazocine was given intravenously, over one minute and a latency period of about 2 minutes was allowed before starting the procedure for analgesic function to take effect. |
| GROUP B (The Paracervical Block) | Experimental | Drug: LidocaineReceived 10 ml of 1% lidocaine, for the blocks with 4ml at 4 O' clock and 8 O'clock positions and 2 ml at the anterior cervical lip. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- - Between the ages of 18- 45 years.
- Spontaneous incomplete miscarriage at less than 13 weeks.
- Not allergic to drugs for the study
- Patients that give consent
Key exclusion criteria (7 listed)
- - Patients who do not consent to MVA [ Manual vacuum aspiration].
- Those with known allergy history to the drug agents.
- Those with septic incomplete miscarriage.
- Patients with infection at the cervical blocking sites.
- Those with active pelvic inflammatory disease.
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 |
|---|---|---|
| LidocaineAlso: XylocaineThe Paracervical Block with lidocaine for manual vacuum aspiration | Drug | GROUP A (Conscious Sedation), GROUP B (The Paracervical Block) |
Primary outcome
Mean pain score using the Visual analogue scale
Time frame: Pain and side effects experienced following the use of the analgesic agents at about 10 minutes, 2 hours, 6 hours, 12 hours and 24 hours following the procedure was noted. Higher score showed more pain and lower score showed lower pain
The primary outcome measure is the mean pain score of the participants in the study groups.
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 6 Aug 2024.
- Background: PubMed 15863551Sotiriadis A, Makrydimas G, Papatheodorou S, Ioannidis JP. Expectant, medical, or surgical management of first-trimester miscarriage: a meta-analysis. Obstet Gynecol. 2005 May;105(5 Pt 1):1104-13. doi: 10.1097/01.AOG.0000158857.44046.a4.
- Individual participant dataSharing planned: No. This will only be after full defense of the work at the college
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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.
DARLINTON-PETER CHIBUZOR C UGOJI, MBBS principal investigator
Alex Ekwueme Federal University Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine in people with Effect of Drug, run by Darlington-Peter Chibuzor Ugoji at 1 site in Nigeria.
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 4 inclusion and 7 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 6 Aug 2024. 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 Nigeria. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean pain score using the Visual analogue scale (time frame: Pain and side effects experienced following the use of the analgesic agents at about 10 minutes, 2 hours, 6 hours, 12 hours and 24 hours following the procedure was noted. Higher score showed more pain and lower score showed lower pain). 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 NCT06539143, 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 6 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.