Vaginal DischargePhase 3LISPRAYNCT05201313
Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations
A Phase 3 study testing Lidocaine Hydrochloride and Mepivacaine Injection in people with Vaginal Discharge and Perineum; Rupture, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
Trial summary
Randomized controlled trial aimed at evaluating the efficacy and safety of the use of a local anesthetic spray, commonly used in clinical practice as off-label, during the suturing of perineal lacerations in post-partum, comparing it with the standard technique that involves the infiltration of lacerated tissues, by… 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
- Vaginal Discharge, Perineum; Rupture, Analgesia
- What is being tested?
- Lidocaine Hydrochloride and Mepivacaine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2022to 8 Aug 2022
- Phase
- Phase 3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have a 1st or 2nd degree postpartum perineal laceration requiring suturing;
- have reached 37 gestational weeks;
- are over 18 years of age;
- had a top birth;
- are able to understand the Italian language;
- have a consent to participate in the study;
Who cannot join
- have received epidural anesthesia within 2 hours prior to delivery;
- had an operative birth;
- have a psychiatric pathology;
- have had a twin birth;
- have experienced adverse reactions to any local anesthetic in the past;
- hypersensitivity to the active substance or to any of the excipients
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- Severe disturbances of the cardiac conduction system
- Acute non compensated heart failure
- Severe arteriopathies
- Severe uncontrolled hypertension
- Intravascular injections
- Septicemia Dysfunction
- Infection at the injection site
- Kidney failure. Providing for the exclusion of patients with severe renal impairment (estimated GFR <30 mL / min / 1.73 m2 at the time of screening).
- Advanced liver dysfunction
- Hyperthyroidism
- Acute angle glaucoma
- Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or 5 half-lives of the study drug
- Any clinical condition that in the investigator's judgment would render the patient unsuitable for the study including, but not limited to, infectious, inflammatory, psychiatric, neurological, cardiological, renal, hepatic, respiratory, diabetes) conditions or laboratory value at clinically meaningful screening that, an investigator's opinion, may present a safety risk, interface with study compliance and follow-up;
- have had in pregnancy liver disease including pre-eclampsia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial to Evaluate the Efficacy of Local Anaesthetic Application in Spray for the Repair of 1st- 2nd Perineal Lacerations Following Vaginal Delivery
Randomized controlled trial aimed at evaluating the efficacy and safety of the use of a local anesthetic spray, commonly used in clinical practice as off-label, during the suturing of perineal lacerations in post-partum, comparing it with the standard technique that involves the infiltration of lacerated tissues, by administering a NRS card at the end of the procedure.
Read the detailed description
The study aims to compare the effectiveness of pain treatment during the suturing of postpartum perineal lacerations with lidocaine spray vs skin infiltration. The hypothesis of the study is that the treatment of perineal pain with nebulization demonstrates comparable efficacy vs the infiltration of mepivacaine hydrochloride in a population of patients subjected to suturing of postpartum lacerations. Eligible women will be randomly assigned to receive, after wound disinfection and cleansing of bleeding with mild haemostasis:
- nebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm (experimental group).
- subcutaneous / submucosal infiltration depending on the type of perineal laceration of 10 ml of 1% mepivacaine hydrochloride (control group).
Since there are no previous published studies, regarding the use of nebulized lidocaine hydrochloride for the suturing of perineal lacerations, the number of puffs chosen was chosen based on what is indicated on the technical data sheet of lidocaine hydrochloride and making use of previous studies in the gynecological field, but with other indications.
The suture will be made once anesthetic efficacy is achieved, as per pharmacological indications. The administration of the anesthetic and the suturing of the lacerations will be performed by the gynecologist or by the gynecology resident who will be working at that time in the delivery room, as is routinely done in our Clinic. The patients will be enrolled consecutively following the order generated by the randomization list itself. By filling in specific pre-set cards, the data will be collected.
Initially, the primary outcome was NRS at the beginning of suturing and NRS at the end of the procedure. In a second moment, the investigators thought it would be better to ensure that adequate analgesia (NRS<4) was achieved for all patients during suturing, rather than varying the dosage of the anesthetic itself. The investigators then decided to reassess pain at successive time points, evaluating it at 0, 2, 4, 12, and 24 hours.
- Conditions
- Vaginal Discharge, Perineum; Rupture, Analgesia
- Being tested
- Lidocaine Hydrochloride, Mepivacaine Injection
- Keywords
- perineal laceration, suturing, anesthetic
- Medical subject headings
- Vaginal Discharge, Rupture, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HydrochlorideDrug
Also called ECOCAIN
nebulization of 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm
Mepivacaine InjectionDrug
Also called MEPIVACAINA CLORIDRATO
subcutaneous / submucosal infiltration depending on the type of perineal tear of 10 ml of 1% mepivacaine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| lidocaine spray | Experimental | nebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm Receives: Drug: Lidocaine Hydrochloride |
| mepivacaine infiltration | Active comparator | subcutaneous / submucosal infiltration depending on the type of perineal tear of 10 ml of 1% mepivacaine hydrochloride Receives: Drug: Mepivacaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS 2
numeric rating scale for pain (0=no pain-10=maximum pain)
Measured: At 2 hours after delivery
NRS 4
numeric rating scale for pain (0=no pain-10=maximum pain)
Measured: At 4 hours after delivery
NRS 12
numeric rating scale for pain (0=no pain-10=maximum pain)
Measured: At 12 hours after delivery
NRS 24
numeric rating scale for pain (0=no pain-10=maximum pain)
Measured: At 24 hours after delivery
NRS o
numeric rating scale for pain (0=no pain-10=maximum pain)
Measured: during suturing
Secondary outcomes (2)
need for additional doses (number of additional nebulizations, presence or absence of additional infiltration)
need for an additional dose of nebulization and / or additional infiltration during the suturing of the postpartum perineal laceration
Measured: during the suture
final satisfaction, assessed via telephonic interview
satisfaction of the puerpera, assessed through the 30 days-follow up, asking for the patient's opinion regarding postpartum pain and any long-term complications
Measured: 30 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start20 Jan 2022
- Primary completion8 Jul 2022
- Study completion8 Aug 2022
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 Vaginal DischargeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (RCT) of superiority, with two parallel treatment arms. Phase 3 study. Randomized controlled single-center perspective study.
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Restaino, Azienda Sanitaria-Universitaria Integrata di Udine
- Investigators
- Lorenza Driul, professor, Study chair, DAME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201313
- Sponsor's protocol ID
- 0042698/P/GEN/ARCS
- Acronym
- LISPRAY
- Status last verified
- Sep 2023
- First submitted
- 4 Jan 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Restaino S, Degano M, Rizzante E, Battello G, Paparcura F, Biasioli A, Arcieri M, Filip G, Vetrugno L, Dogareschi T, Bove T, Petrillo M, Capobianco G, Vizzielli G, Driul L; LISPRAY Group. Lidocaine spray vs mepivacaine local infiltration for suturing 1st/2nd grade perineal lacerations: a randomised controlled non-inferiority trial. BMC Pregnancy Childbirth. 2024 Jun 24;24(1):439. doi: 10.1186/s12884-024-06640-7.
PubMed 38914976
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Evaluate the Efficacy of Local Anaesthetic Application in Spray for the Repair of 1st- 2nd Perineal Lacerations Following Vaginal Delivery
- ClinicalTrials.gov ID
- NCT05201313
- Acronym / sponsor ID
- LISPRAY / 0042698/P/GEN/ARCS
- Conditions
- Vaginal Discharge, Perineum; Rupture, Analgesia
- Keywords
- perineal laceration, suturing, anesthetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 21 Jan 2022 (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.
Randomized controlled trial aimed at evaluating the efficacy and safety of the use of a local anesthetic spray, commonly used in clinical practice as off-label, during the suturing of perineal lacerations in post-partum, comparing it with the standard technique that involves the infiltration of lacerated tissues, by administering a NRS card at the end of the procedure.
Detailed description
The study aims to compare the effectiveness of pain treatment during the suturing of postpartum perineal lacerations with lidocaine spray vs skin infiltration. The hypothesis of the study is that the treatment of perineal pain with nebulization demonstrates comparable efficacy vs the infiltration of mepivacaine hydrochloride in a population of patients subjected to suturing of postpartum lacerations. Eligible women will be randomly assigned to receive, after wound disinfection and cleansing of bleeding with mild haemostasis:
- nebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm (experimental group).
- subcutaneous / submucosal infiltration depending on the type of perineal laceration of 10 ml of 1% mepivacaine hydrochloride (control group).
Since there are no previous published studies, regarding the use of nebulized lidocaine hydrochloride for the suturing of perineal lacerations, the number of puffs chosen was chosen based on what is indicated on the technical data sheet of lidocaine hydrochloride and making use of previous studies in the gynecological field, but with other indications.
The suture will be made once anesthetic efficacy is achieved, as per pharmacological indications. The administration of the anesthetic and the suturing of the lacerations will be performed by the gynecologist or by the gynecology resident who will be working at that time in the delivery room, as is routinely done in our Clinic. The patients will be enrolled consecutively following the order generated by the randomization list itself. By filling in specific pre-set cards, the data will be collected.
Initially, the primary outcome was NRS at the beginning of suturing and NRS at the end of the procedure. In a second moment, the investigators thought it would be better to ensure that adequate analgesia (NRS<4) was achieved for all patients during suturing, rather than varying the dosage of the anesthetic itself. The investigators then decided to reassess pain at successive time points, evaluating it at 0, 2, 4, 12, and 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT) of superiority, with two parallel treatment arms. Phase 3 study. Randomized controlled single-center perspective study.
| Arm | Type | Receives |
|---|---|---|
| lidocaine spray | Experimental | Drug: Lidocaine Hydrochloridenebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm |
| mepivacaine infiltration | Active comparator | Drug: Mepivacaine Injectionsubcutaneous / submucosal infiltration depending on the type of perineal tear of 10 ml of 1% mepivacaine hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have a 1st or 2nd degree postpartum perineal laceration requiring suturing;
- have reached 37 gestational weeks;
- are over 18 years of age;
- had a top birth;
- are able to understand the Italian language;
Key exclusion criteria (20 listed)
- have received epidural anesthesia within 2 hours prior to delivery;
- had an operative birth;
- have a psychiatric pathology;
- have had a twin birth;
- have experienced adverse reactions to any local anesthetic in the past;
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 |
|---|---|---|
| Lidocaine HydrochlorideAlso: ECOCAINnebulization of 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm | Drug | lidocaine spray |
| Mepivacaine InjectionAlso: MEPIVACAINA CLORIDRATOsubcutaneous / submucosal infiltration depending on the type of perineal tear of 10 ml of 1% mepivacaine hydrochloride | Drug | mepivacaine infiltration |
Primary outcome
NRS 2
Time frame: At 2 hours after delivery
numeric rating scale for pain (0=no pain-10=maximum pain)
NRS 4
Time frame: At 4 hours after delivery
numeric rating scale for pain (0=no pain-10=maximum pain)
NRS 12
Time frame: At 12 hours after delivery
numeric rating scale for pain (0=no pain-10=maximum pain)
NRS 24
Time frame: At 24 hours after delivery
numeric rating scale for pain (0=no pain-10=maximum pain)
NRS o
Time frame: during suturing
numeric rating scale for pain (0=no pain-10=maximum pain)
2 secondary outcomes
need for additional doses (number of additional nebulizations, presence or absence of additional infiltration)
Time frame: during the suture
final satisfaction, assessed via telephonic interview
Time frame: 30 days follow up
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 21 Sep 2023.
- Derived from this study: PubMed 38914976Restaino S, Degano M, Rizzante E, Battello G, Paparcura F, Biasioli A, Arcieri M, Filip G, Vetrugno L, Dogareschi T, Bove T, Petrillo M, Capobianco G, Vizzielli G, Driul L; LISPRAY Group. Lidocaine spray vs mepivacaine local infiltration for suturing 1st/2nd grade perineal lacerations: a randomised controlled non-inferiority trial. BMC Pregnancy Childbirth. 2024 Jun 24;24(1):439. doi: 10.1186/s12884-024-06640-7.
- Individual participant dataSharing planned: No
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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.
Lorenza Driul, professor study chair
DAME
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine Hydrochloride and Mepivacaine Injection in people with Vaginal Discharge and Perineum; Rupture, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
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 20 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 21 Sep 2023. 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 Italy. 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 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?
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?
NRS 2 (time frame: At 2 hours after delivery). The study lists 5 primary outcomes in all. 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 NCT05201313, 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 21 Sep 2023.