Can PLIA Reduce Early Post-operative Pain After PAO Surgery?

Официальное название

Peri-incisional Local Infiltration to Improve Pain Control After Periacetabular Osteotomy

Обзор

The goal of this clinical trial is to compare different peri-incisional local infiltrative anesthesia (PLIA) methods in patients ages 13 to 50 undergoing a periacetabular osteotomy (PAO). The main questions to answer here are: 1. Does PLIA impact post-operative pain after PAO? 2. Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO? 3. Does the timing of PLIA administration impact post-operative pain and MED after PAO? Participants will be asked to complete some surveys; demographics survey, General Self-Efficacy Scale (GSE) and the Pain Resilience Scale. All other information will be gathered from the patients medical chart. Researchers will compare three groups. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.

Подробное описание

Patients will be approached at their preoperative appointment. This is the only time researchers will conduct study related activities with patients. All other information will be gathered by chart review. Following consent, patients will be asked to complete surveys through REDCap® using a tablet or computer. These include a self-efficacy survey and a grit survey. Patients will then be randomized in a 1:1:1 ratio. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.

Patients will be blinded to which group they are in, meaning they will not know whether they received the injection or not. Patients may ask to be told what study group they were in at their standard-of-care, 3 month follow-up visit.

Following surgery, patients in all treatment arms will be provided with the same intravenous (patient-controlled analgesia) and oral pain medications scheduled as needed per standard of care.

The research team will review patient medical records to record narcotic use and visual analog scale (VAS) pain scores post-operatively until discharge from the hospital.

Вмешательства

• Комбинированный продукт Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)
  Weight 50-74.9 kg: * ropivacaine 100mg/epinephrine 50 mcg/ketorolac 15mg in NaCl 0.9% 60mL * 2 vials of this for 120mL total Weight 75-99.9 kg: * Ropivacaine 150mg/epinephrine 100 mcg/ketorolac 15mg in NaCl 0.9% 60mL * 2 vials of this for 120mL total Weight 100+ kg: * Ropivacaine 200mg/epinephrine 150 mcg/ketorolac 15 mg in NaCl 0.9% 60mL * 2 vials of this for 120mL total

Первичные конечные точки

• Post-operative pain after periacetabular osteotomy. [Срок оценки: Post Anesthesia Care Unit (PACU), 24 hours post op]
• Pain medication usage after periacetabular osteotomy. [Срок оценки: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.]
• The impact of timing of PLIA administration on post-operative pain. [Срок оценки: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.]
• The impact of timing of PLIA administration on MED. [Срок оценки: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.]

Вторичные конечные точки (3)

• Assessment on depression (PHQ-9) [Срок оценки: Preoperative]
• General Self-Efficacy Scale (GSE) [Срок оценки: Preoperative]
• Pain Resilience Scale. [Срок оценки: Preoperative]

Критерии участия

Критерии включения

• Adolescent or young adult diagnosed with hip dysplasia indicated for PAO at University of Iowa Hospital and Clinics.

Критерии исключения

• Unable to provide informed consent.
• Pregnant or breast-feeding individuals
• Prisoner or ward of the state
• Allergy or medical contradiction to any of the study medications
• Patients undergoing femoral osteotomy or surgical hip dislocation with PAO will be excluded

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Iowa Health Care — Iowa City

Идентификаторы

NCT: NCT06519955 · 202311233

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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