Clinical Trials Logo

Clinical 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 administering a NRS card at the end of the procedure.


Clinical Trial 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: 1. nebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm (experimental group). 2. 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


Related Conditions & MeSH terms


NCT number NCT05201313
Study type Interventional
Source Azienda Sanitaria-Universitaria Integrata di Udine
Contact
Status Completed
Phase Phase 3
Start date January 20, 2022
Completion date August 8, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05534230 - Dexmedetomidine for Pain Reduction in CABG N/A
Recruiting NCT04436224 - Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation Phase 4
Not yet recruiting NCT04548323 - Hypoalgesic Effects of Walking and Running Imagined
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT04394481 - Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery Phase 4
Completed NCT04690647 - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement. N/A
Completed NCT05034601 - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure N/A
Completed NCT03740815 - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection N/A
Recruiting NCT05454202 - Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Recruiting NCT04554186 - Serratus Anterior Plane Block Versus Thoracic Paravertebral Block. N/A
Suspended NCT04860635 - Safety of F14 Following Total Knee Replacement Phase 2/Phase 3
Not yet recruiting NCT04519463 - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing Early Phase 1
Completed NCT02916342 - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks Phase 4
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Not yet recruiting NCT02549118 - Tenoxicam for Intrapartum Analgesia Phase 2
Not yet recruiting NCT02190760 - Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block. N/A
Completed NCT01789606 - Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet Phase 3
Completed NCT01299584 - ULTIVA Post Marketing Surveillance N/A
Completed NCT00137085 - Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation N/A
Terminated NCT04495374 - Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy Phase 4