Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery

Официальное название

Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery: a Randomised Controlled Trial

Обзор

Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory/cardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.

Вмешательства

• Препарат 0.012%diprospan+0.5%ropivacaine
  At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.5ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare dipros
• Препарат 0.009%diprospan+0.5%ropivacaine
  At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.375ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare dipr
• Препарат 0.006%diprospan+0.5ropivacaine
  At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.25ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare dipro
• Препарат 0.003%diprospan+0.5%ropivacaine
  At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.125ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare dipr
• Препарат 0.5%ropivacaine
  At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 15 ml of ropivacaine will be diluted to 30 ml with in 0.9% NaCl, respectively. The surgeon will use

Первичные конечные точки

• postoperative sufentanil consumption via PCA [Срок оценки: At 48 hours after the operation]

Вторичные конечные точки (12)

• Cumulative consumption of sufentanil by PCA [Срок оценки: During 0-4hours, 4-8hours, 8-24hours and 24-48hours after operation]
• PCA pump first press time [Срок оценки: Within 48 hours after the operation.]
• VAS score at during movement (VASm) and at rest (VASr) [Срок оценки: At 2hours, 4hours, 8hours, 24hours, 48hours, 72hours, 1week, 2weeks, 6weeks, 3months postoperatively]
• Intraoperative opioid dosage [Срок оценки: During the operation]
• Time to first analgesic remediation [Срок оценки: Until 3 months after surgery]
• Amount of postoperative oral analgesic remediation [Срок оценки: Until 3 months after surgery]
• Postoperative nausea and vomiting (POVN) [Срок оценки: At 2hours, 4hours, 8hours, 24hours, and 48hours postoperatively]
• Ramsay sedation score (RSS) [Срок оценки: At 2hours, 4hours, 8hours, 24hours, 48hours postoperatively]
• Satisfaction score [Срок оценки: At 2hours, 4hours, 8hours, 24hours, 48hours, 72hours, 1week, 2weeks, 6weeks, 3months postoperatively]
• The World Health Organization Quality of Life (WHOQOL) [Срок оценки: At 3months postoperatively]
• Oswestry disability index (ODI) [Срок оценки: At 3months postoperatively]
• Patient and Observer Scar Assessment Scale (POSAS) [Срок оценки: At 3months postoperatively]

Критерии участия

Критерии включения

Patients scheduled for spine surgery under general anesthesia. Anticipated cervical, thoracic, and lumbar spine surgeries (within three level).

Patients age 18-65 years. American Society of Anaesthesiologists Classification of I or II.

Критерии исключения

Patients refuse to participate. Patients who are allergic to ropivacaine, betamethasone and opioid, . Pateints who have been abusing drugs or alcohol. Patients who have abnormalities in kidney or liver function tests. BMI<15kg/m2 or>35 kg/m2. Patient has a history of spinal surgery. Patient has peri-incisional infection. Patient has a history of stroke or other serious neurological disease. Patient has a history of diabetes and other metabolic disorders. Patient has a history of psychological disorders. Patient is on systemic steroids. Patient is pregnant or breastfeeding. Glasgow Coma Scale score < 15 before surgery. Unable to provide written informed consent.

Withdrawal criteria:

Voluntary withdrawal. Delayed extubation. Poor cognitive function within 48 hours after surgery. Postoperative radiation therapy or chemotherapy during follow-up. Postoperative diagnosis of spinal cord or nerve root injury resulting in pain during follow-up.

Reoperation during follow-up.

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

Профилактика

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Публикации

• Wang Y, Han B, Zhao C, Ren H, Jia W, Luo F. Minimum effective dose of betamethasone for incisional local infiltration for the prevention of postoperative pain after spine surgery: study protocol for a randomised controlled trial. BMJ Open. 2025 Sep 28;15(9):e100725. doi: 10.1136/bmjopen-2025-100725. PMID 41022457

Идентификаторы

NCT: NCT06785350 · KY2024-365-02-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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