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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine spray | Experimental | nebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm |
|
| mepivacaine infiltration | Active Comparator | subcutaneous / submucosal infiltration depending on the type of perineal tear of 10 ml of 1% mepivacaine hydrochloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Hydrochloride | Drug | nebulization of 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm |
|
| Measure | Description | Time Frame |
|---|---|---|
| NRS 2 | numeric rating scale for pain (0=no pain-10=maximum pain) | At 2 hours after delivery |
| NRS 4 | numeric rating scale for pain (0=no pain-10=maximum pain) | At 4 hours after delivery |
| NRS 12 | numeric rating scale for pain (0=no pain-10=maximum pain) | At 12 hours after delivery |
| NRS 24 | numeric rating scale for pain (0=no pain-10=maximum pain) | At 24 hours after delivery |
| NRS o | numeric rating scale for pain (0=no pain-10=maximum pain) | during suturing |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | during the suture |
| final satisfaction, assessed via telephonic interview |
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Inclusion Criteria:
Exclusion Criteria:
- have received epidural anesthesia within 2 hours prior to delivery;
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| Name | Affiliation | Role |
|---|---|---|
| Lorenza Driul, professor | DAME | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASUFC | Udine | 33100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38914976 | Derived | 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. |
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Randomized controlled trial (RCT) of superiority, with two parallel treatment arms.
Phase 3 study. Randomized controlled single-center perspective study.
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Open label: due to the different methods of administration, the blindness of the obstetrician-gynecological team cannot be guaranteed.
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| Mepivacaine Injection | Drug | subcutaneous / submucosal infiltration depending on the type of perineal tear of 10 ml of 1% mepivacaine hydrochloride |
|
|
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 |
| 30 days follow up |
| ID | Term |
|---|---|
| D019522 | Vaginal Discharge |
| D012421 | Rupture |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014947 | Wounds and Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D008619 | Mepivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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