Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae

Официальное название

Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae: A Prospective Randomized, Double-Blind, Clinical Trial

Обзор

In this study, we will compare the effect and safety of lignocaine versus bupivacaine infiltration for postpartum perineal pain after vaginal delivery with episiotomy in primigravidae.

Подробное описание

Episiotomy is the most common procedure used for dilatation of the vaginal opening for giving birth. Although episiotomy is associated with benefits for the mother, it may lead to short term and long-term disabilities, including postpartum perineal pain that is secondary to perineal tearing. The perineal pain experienced due to receiving an episiotomy is severe during the first few days after delivery, and it can lead to limitations in movement and difficulties with urination and defecation.

Bupivacaine is a long-acting local anesthetic that effectively reduces postoperative pain. In practice, bupivacaine is used for infiltration anesthesia, nerve blocks, epidural, and caudal anesthesia. It has a more selective effect on sensory nerve fibers as compared to motor nerve fibers, therefore is preferred in obstetrics.

Lignocaine infiltration, with the presence or absence of epidural anesthesia, is the most frequently employed local anesthetic in ameliorating postpartum perineal pain. It is a rapid-onset amide local anesthetic with a short duration of action lasting up to two hours.

Вмешательства

• Препарат Lignocaine
  A perineal infiltration of a 5-ml of the drug (100 mg of lignocaine) in the margins of the episiotomy. Careful aspiration before and during injection of the product should be performed to prevent intravascular injection. The entire contents will then be injected slowly at several points of infiltration. All planes will be infiltrated (vagina, muscle, and skin) before episiotomy repair.
• Препарат Bupivacaine
  A perineal infiltration of a 5-ml of the study drug (20 mg of Bupivacaine) in the margins of the episiotomy. Careful aspiration before and during injection of the product should be performed to prevent intravascular injection. The entire contents will then be injected slowly at several points of infiltration. All planes will be infiltrated (vagina, muscle, and skin) before episiotomy repair.

Первичные конечные точки

• Degree of pain [Срок оценки: 6 hours postoperatively]

Вторичные конечные точки (4)

• The time till first analgesic requirement [Срок оценки: 6 hours postoperatively]
• Total analgesics consumption [Срок оценки: 12 hours postoperatively]
• Incidence of compilation [Срок оценки: 6 hours postoperatively]
• Time of post-operative ambulation [Срок оценки: 12 hours postoperatively]

Критерии участия

Критерии включения

• Primigravidae with the full term undergoing vaginal delivery with episiotomy.
• Pregnancies and singleton vertex cephalic fetuses.
• In the active phase of the first stage of labor.

Критерии исключения

• Patients with history of drug allergies to study drugs as this will increase the risk of complications.
• Patients undergoing vaginal delivery under epidural or spinal anesthesia as they will affect post-operative pain and interfere with assessment of efficacy of local infiltration of the study drugs.
• Evidence of local infection at site of injection as this will interfere with the action of the study drug and will increase the risk of complications.
• Inability to cooperate as this will affect our assessment.
• Patient's refusal.
• Any intraoperative complications that will affect our outcome criteria (bleeding, organ injury) as they will affect patient's vital data and affect our assessment.
• Neurological comorbidities (chronic pain disorder, chronic systemic disease, neurological disorder, neuropathic pain) as they will need more analgesia.
• Drug abuse as they will be tolerant to the used analgesics.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Ain Shams University — Cairo

Идентификаторы

NCT: NCT06568289 · FMASUMS167/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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