Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy

Официальное название

Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy: A Prospective Randomized Study

Обзор

This study evaluates whether combining two distinct pain-relief techniques-a peripheral nerve block called the Erector Spinae Plane Block (ESPB) and a low-dose spinal medication injection called Intrathecal Morphine (ITM)-provides better postoperative pain management for adult patients undergoing major midline abdominal surgery (laparotomy) compared to using either technique alone. The main goal is to see if this combination improves pain control and reduces the total amount of opioids required by patients within the first 48 hours after surgery.

Вмешательства

• Препарат Intrathecal Morphine
  Administration of a single-shot intrathecal injection containing hyperbaric bupivacaine combined with preservative-free morphine (ITM) during spinal anesthesia prior to the surgical incision."
• Процедура Erector Spinae Plane Block
  Bilateral ultrasound-guided erector spinae plane block performed at the T8-T10 level using a local anesthetic solution (such as bupivacaine or ropivacaine) injected deep to the erector spinae muscle fascia for postoperative abdominal analgesia.

Первичные конечные точки

• Time to First Rescue Analgesia [Срок оценки: Up to 48 hours postoperatively.]
• Postoperative Pain Intensity [Срок оценки: At rest and during a standardized cough at 0, 2, 4, 6, 12, 24, and 48 hours postoperatively.]
• Cumulative Opioid Consumption [Срок оценки: Up to 48 hours postoperatively.]

Вторичные конечные точки (6)

• Time to First Ambulation [Срок оценки: Up to hospital discharge (typically up to 7 days).]
• Time to Readiness for PACU Discharge [Срок оценки: Within the first 24 hours postoperatively.]
• Incidence of Adverse Events [Срок оценки: Up to 48 hours postoperatively.]
• Patient Satisfaction with Pain Management [Срок оценки: Assessed at 48 hours postoperatively.]
• Quality of Recovery [Срок оценки: Postoperative Day 1 (approximately 24 hours).]
• Healthcare Utilization [Срок оценки: From day of surgery to hospital discharge (up to 30 days).]

Критерии участия

Inclusion Criteria Patients scheduled to undergo elective or emergency midline exploratory laparotomy.

American Society of Anesthesiologists (ASA) physical status I, II, or III. Intact cognitive ability to comprehend study procedures, use the Numeric Rating Scale (NRS) accurately, and provide informed consent.

Exclusion Criteria Contraindications to regional or neuraxial anesthesia (e.g., patient refusal, localized infection at needle insertion sites, known coagulopathy (INR >1.5 or platelet count <80,000/\\mu L), or un-pausable therapeutic anticoagulation).

Known allergy or severe hypersensitivity to local anesthetics or morphine. Chronic pain conditions requiring daily opioid consumption for >3 months preoperatively.

Documented history of substance use disorder. Severe chronic respiratory disease (e.g., COPD requiring home oxygen therapy, or severe obstructive sleep apnea not managed with CPAP).

Neurological or psychiatric conditions that compromise sensory perception or communication.

Surgical incisions planned to extend significantly past the midline. Severe spinal deformities or a history of spinal surgery at the targeted block/injection interspaces.

Concurrent enrollment in any other interventional clinical trial.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Sohag University Hospital — Sohag

Публикации

• Beverly A, Kaye AD, Ljungqvist O, Urman RD. Essential Elements of Multimodal Analgesia in Enhanced Recovery After Surgery (ERAS) Guidelines. Anesthesiol Clin. 2017 Jun;35(2):e115-e143. doi: 10.1016/j.anclin.2017.01.018. PMID 28526156

Идентификаторы

NCT: NCT07720739 · Soh-Med-26-6-13MS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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