Comparison of the Efficacy of the Pericapsular Nerve Group (PENG) Block Versus Intrathecal Morphine for Postoperative Analgesia Following Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Cumulative oxycodone consumption delivered via patient-controlled analgesia (PCA)
研究概览
简要总结
The Pericapsular Nerve Group (PENG) block is an effective method for postoperative pain management in patients undergoing primary total hip arthroplasty (THA) via a posterolateral approach. The application of this technique reduces postoperative opioid requirements, thereby limiting the risk of adverse effects associated with systemic opioid administration. Effective pain control and a reduced incidence of side effects may translate into higher patient satisfaction and a decreased length of hospital stay (LOS). The PENG block serves as an effective component of multimodal analgesia and may provide an alternative to intrathecal morphine in patients undergoing primary total hip arthroplasty via a posterolateral approach, where the primary anesthetic technique is spinal anesthesia with hyperbaric bupivacaine.
Objectives
- To evaluate the efficacy of the PENG block in postoperative pain control and compare its effectiveness with intrathecal morphine administration.
- To assess the impact of the PENG block on postoperative opioid consumption in comparison to analgesia achieved via intrathecal morphine.
- To analyze the incidence of selected adverse effects associated with systemic opioid administration in patients receiving a PENG block versus those in the intrathecal morphine group.
- To evaluate patient satisfaction levels regarding postoperative pain management across the different analgesic modalities.
- To analyze the correlation between the type of analgesia employed and the duration of hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed, written consent for study participation.
- •Qualification for elective primary total hip arthroplasty via a posterolateral approach.
- •Age above 18 years.
- •ASA Physical Status I-III.
- •Absence of contraindications to spinal anesthesia.
- •Absence of contraindications to performing a Pericapsular Nerve Group (PENG) block.
- •Absence of contraindications to the administration of the pharmacological agents utilized in the study.
排除标准
- •Absence of informed consent.
- •Age below 18 years.
- •Psychoactive substance abuse or dependence.
- •Chronic opioid therapy.
- •Contraindications to spinal anesthesia.
- •Contraindications to the Pericapsular Nerve Group (PENG) block.
- •Contraindications to the administration of study medications.
- •Body Mass Index (BMI) above 30 kg/m^
- •Pregnancy.
- •History of chronic pain management.
研究组 & 干预措施
PENG Group
Spinal anesthesia without opioid + PENG block
干预措施: PNEG block (Procedure)
PENG Group
Spinal anesthesia without opioid + PENG block
干预措施: Spinal anesthesia without opioid (Procedure)
MF Group
Spinal anesthesia with opioid and sham PENG Block
干预措施: Spinal anesthesia with opioid (Procedure)
MF Group
Spinal anesthesia with opioid and sham PENG Block
干预措施: Sham PENG block (Procedure)
Control
Spinal anesthesia without opioid and sham PENG Block
干预措施: Spinal anesthesia without opioid (Procedure)
Control
Spinal anesthesia without opioid and sham PENG Block
干预措施: Sham PENG block (Procedure)
结局指标
主要结局
Cumulative oxycodone consumption delivered via patient-controlled analgesia (PCA)
时间窗: From end of surgery to 24 hours postoperatively.
Total amount of oxycodone delivered by the intravenous PCA pump, calculated as the sum of all delivered PCA boluses and reported in milligrams. Lower values indicate lower postoperative opioid requirement.
Number of patient-initiated PCA demand attempts recorded by the PCA pump
时间窗: From end of surgery to 24 hours postoperatively.
Total number of patient-initiated analgesia requests (button presses) recorded by the intravenous patient-controlled analgesia (PCA) pump. This measure includes all demand attempts, regardless of whether a bolus was delivered. Reported as count.
Pain intensity at rest measured by the 11-point Numerical Rating Scale (NRS, 0-10)
时间窗: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.
Patient-reported pain intensity at rest assessed using the 11-point Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain score is recorded at each scheduled assessment time point.
Dynamic pain assesmnetDynamic pain intensity during passive straight leg raise measured by the 11-point Numerical Rating Scale (NRS, 0-10)
时间窗: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.
Patient-reported dynamic pain intensity during passive straight leg raise of the operated limb (knee extended and hip flexed to 45°), assessed using the 11-point Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain score is recorded at each scheduled assessment time point.
Patient satisfaction with postoperative analgesia measured by a 5-point Likert satisfaction scale (1-5)
时间窗: At 0, 4, 8, 12, and 24 hours after surgery.
Patient-reported satisfaction with postoperative analgesia assessed using a 5-point Likert satisfaction scale: 1. = definitely dissatisfied, 2. = dissatisfied, 3. = neither satisfied nor dissatisfied (neutral), 4. = satisfied, 5. = definitely satisfied. Higher scores indicate greater satisfaction.
次要结局
- Antiemetic Consumption(Within the first 24 hours following the completion of surgery)
- Nausea severity(Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively)
- Pruritus Severity(Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively)
- Postoperative length of hospital stay (days)(From hospital admission to hospital discharge (assessed at hospital discharge).)
- Sedation and agitation level measured by the Richmond Agitation-Sedation Scale (RASS, -5 to +4)(At 0, 4, 8, 12, and 24 hours after surgery.)
- Motor blockade measured by the Bromage motor blockade scale (Grade 0-3)(At 0, 4, 8, 12, and 24 hours after surgery.)
- Sensory blockade(At 0, 4, 8, 12, and 24 hours postoperatively.)
- Intraoperative blood loss (mL)(Intraoperatively (from skin incision to skin closure).)
- Duration of surgery (minutes)(Intraoperatively (from skin incision to skin closure).)
- Participants requiring intraoperative vasopressors(Intraoperatively (from skin incision to skin closure).)
- Heart rate (beats per minute)(Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.)
- Peripheral oxygen saturation (SpO2, %)(Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.)
- Diastolic blood pressure (DBP, mmHg)(Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.)
- Mean arterial pressure (MAP, mmHg)(Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.)
- Time to first mobilization (hours)(From administration of spinal anesthesia until hospital discharge (time to first mobilization assessed at first mobilization, through study completion an average of 24 hours postoperatively).)
- Number of participants with predefined anesthesia-related complications(From hospital admission to hospital discharge (assessed daily during hospitalization and at discharge, through study completion an average 5 days postoperatively).)
- Number of participants with predefined hospitalization-related complications(From hospital admission to hospital discharge (assessed daily during hospitalization and at discharge, through study completion an average 5 days postoperatively).)