Comparative Study Between Continous Ultrasound Guided Pericapsular Nerve Group (PENG) Block Versus Femoral Nerve Block For Perioperative Pain Control In Hip Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
The aim of this study is to compare the efficacy of the ultrasound- guided pericapsular nerve group (PENG) block versus the femoral nerve block (FNB) for postoperative pain control in patients undergoing hip surgeries, specifically evaluating pain scores and quadriceps strength.
详细描述
Study Design:
This is a single-center, double-blinded, randomized comparative trial will be conducted on patients for perioperative pain control in patients undergoing hip surgeries conducted at Anesthesia and ICU Department Benha university Hospital during the period from May 2025 to June 2026. Written informed consent will be acquired from all participants.
Inclusion Criteria:
Patients eligible for inclusion in the study if they met the following criteria:
- Aged 40 years or older.
- Presenting for hip surgeries
- No contraindications to regional anesthesia.
- Time of surgery up to 3 hours
- ASA I-III
- Able to provide written informed consent.
- Able to reliably report pain and other symptoms to the research team.
- Undergoing elective or emergency hip surgeries. Exclusion Criteria Patients will be excluded from participation in the study if they met any of the following criteria:
- Inability to provide first-person consent due to cognitive impairment.
- Presence of a language barrier that would preclude reliable reporting of symptoms or understanding study procedures.
- More than ASA III. 4
- Previous neurological deficit in the lower limbs.
- Local infection at block area.
- Lengthy surgeries more than 3 hours. Methods Sample Size Calculation GPower® version 3.1.9.4 program (5) was used for calculations of sample size, statistical calculator based on 95% confidence interval and power of the study 95% with α error 5%, and effect size of 0.55. According to a previous study (6). Based on this assumption, sample size is calculated to be 66 cases (33 cases for each group) were enough to find such a difference. Randomization and Blindness Patients meeting the inclusion criteria will be randomly assigned in a 1:1 ratio to receive either an ultrasound-guided Pericapsular Nerve Group (PENG) block or an ultrasound-guided Femoral Nerve Block (FNB) using an online randomization computer generator. To ensure blinding of the study, the anesthesiologist placing the block will be different from the anesthesiologist managing the patient outcome intraoperatively and postoperatively. Study Interventions The allocated nerve block will be administered 1 hour preoperatively under ultrasound guidance with catheter insertion for continuous nerve block in both groups, a total volume of 20 mL of 0.5% plain marcaine will be injected and continuous infusion rate of 5-10ml per hour of plain bupivacaine 0.25%. All patients will receive standardized spinal anesthesia using 2.5-3 ml of 0.5% hyperbaric bupivacaine with 25 µg fentanyl as an additive. The technique of spinal anesthesia will be through Midline or paramedian approach at L3-L4 or L4-L5 interspace. Sedation with IV midazolam or propofol may be used as needed. Supplemental oxygen will be provided via nasal cannula or face mask. If spinal anesthesia is contraindicated or fails, patients may be converted to general anesthesia and excluded from final analysis. Outcome Measures
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
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40 years or older.
- •Presenting for hip surgeries
- •No contraindications to regional anesthesia.
- •Time of surgery up to 3 hours
- •ASA I-III
- •Able to provide written informed consent.
- •Able to reliably report pain and other symptoms to the research team.
- •Undergoing elective or emergency hip surgeries.
排除标准
- •Inability to provide first-person consent due to cognitive impairment.
- •Presence of a language barrier that would preclude reliable reporting of symptoms or understanding study procedures.
- •More than ASA III. 4
- •Previous neurological deficit in the lower limbs.
- •Local infection at block area.
- •Lengthy surgeries more than 3 hours.
研究者
Mohamed swera
Asistant lecetruer
Benha University
