Efficacy of Combined Nalbuphine-bupivacaine Versus Dexamethasone-bupivacaine in Pericapsular Nerve Group Block (PENG) for Postoperative Analgesia in Hip Surgeries: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- The time to first request of rescue analgesia
研究概览
简要总结
The aim of the study to Evaluate the efficacy of nalbuphine-bupivacaine vs dexamethasone-bupivacaine in ultrasound guided pericapsular nerve group (PENG) block for improving pain management, reducing opioid consumption, and enhancing the overall analgesic effect in patients undergoing hip surgeries.
详细描述
- To measure the time of first request of rescue analgesia , the total amount of rescue analgesic consumption (pethidine) in the first 24 hours post-operatively in each group and number of patients received one or two doses rescue analgesia.
- To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive flexion or extension of hip (dynamic).
- To assess the incidence of drug-related side effects (such as nausea, vomiting, bradycardia, hypotension, sedation and hyperglycemia) or block -related side effects (hematoma, infection or LA toxicity) in patients receiving either nalbuphine or dexamethasone as adjuvant to bupivacaine in the PENG block.
- To assess Ease of Spinal Positioning (EOSP).
- To assess patient satisfaction.
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)
盲法说明
Anesthetist not sharing in the study will assess patient
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients acceptance.
- •Age: Adults aged 21-75 years old.
- •BMI: 25-30 kg/m2
- •Sex: both sexes (males or females).
- •Patients undergoing unilateral hip surgery under spinal anesthesia.
- •ASA (American Society of Anesthesiologists) physical status classification I, II and Ⅲ..
排除标准
- •Patients with contraindications to regional anesthesia (e.g. local or systemic infections, or severe neurological or muscular disorders or patient on anticoagulant).
- •Allergy to study drugs: bupivacaine or nalbuphine or dexamethasone
- •Patients with severe cardiovascular, respiratory, renal, or hepatic conditions, uncontrolled diabetes diseases, or those undergoing chronic opioid therapy.
- •Psychiatric disorders that hinder informed consent or study participation.
- •history of neurological diseases or conditions that would affect the efficacy of nerve blocks (e.g., neuropathy, spinal cord injury, or history of severe muscle weakness).
研究组 & 干预措施
Group Bupivacaine + dexamethasone (D)
Patients in this group will receive a unilateral ultrasound-guided PENG block with a combination of 20 mL of bupivacaine 0.25%- , 1 ml dexamethasone (4 mg) and 1 ml saline, with total volume 22ml
干预措施: Group Dexamethasone (Procedure)
Group Bupivacaine + nalbuphine (N)
Patients in this group will receive a unilateral ultrasound-guided pericapsular nerve group (PENG) block with a combination of 20 mL of bupivacaine 0.25%- and 2 ml nalbuphine (20 mg), with total volume 22ml
干预措施: Group Nalupnine (Procedure)
结局指标
主要结局
The time to first request of rescue analgesia
时间窗: 24 hours postoperative
(time from end of local anesthetics injection in PENG block till time of NRS \>3) will be recorded.
次要结局
- Number of patients received one or two doses rescue analgesia(24 hours)
- Length of hospital stay(up to 5 days)
- postoperative pain by Numerical Rating Scale(Basal (before giving the block), 15 minutes after giving the block and before spinal anesthesia, PACU ( after arrival to PACU 0 minute), 2 hours (hrs), 4 hrs, 8 hrs, 12 hrs and 24 hrs.)
- To assess the total amount of rescue analgesic consumption(24 hours postoperative)
- To assess the incidence of drug-related side effects or block -related side effects(24 hours postoperative)
- Ease of Spinal Positioning (EOSP)(up to 15 minutes after giving the block)
- patient's satisfaction(24 hours postoperative)
研究者
Dina Abdelhameed Elsadek Salem
PRINCIPLE INVESTIGATOR
Zagazig University