Sacral Erector Spinae Plane Block Versus Pericapsular Nerve Group Block For Analgesia In Hip Hemi Arthroplasty: A Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Numerical pain rating score (NPRS) after surgery at rest.
研究概览
简要总结
Sacral erector spinae plane block(S-ESPB) has been recently described. Case reports are showing that it is useful in various types of surgery. In case presentations, it has been reported as effective in providing analgesia in the posterior branches of the sacral nerves in pilonidal sinus surgery, in the treatment of radicular pain at the L5 - S1 level, after a sex reassignment operation and hypospadias surgery, and its use in combination with lumbar ESPB for analgesia was reported after hip prosthesis surgery . Described in 2018, pericapsular nerve group (PENG) block selectively targets the articular branches of the femoral and accessory obturator nerves thereby providing potential motorsparing analgesia for hip surgery
. Recent studies found that PENG block targets the articular branches of the femoral and accessory obturator nerves, only anesthetizes the anterior hip joint sparing posterior part , as well as there was a motor impairment after block which is from local anesthetic (LA) diffusion to the femoral nerve
. Motor-sparing regional anesthesia techniques have emerged as a safer alternative, balancing effective pain relief with the preservation of quadriceps function . These techniques align with Enhanced Recovery After Surgery (ERAS) protocols, which emphasize multimodal pain control, opioid minimization, and early mobility to reduce complications such as venous thromboembolism (VTE) and postoperative pneumonia
.
详细描述
Study design This double-blinded, prospective, randomized comparative study will be conducted in Fayoum University hospital after the approval of local Institutional Ethics Committee and local institutional review board. Written informed consent will be obtained from all patients for these scientific contributions before recruitment and randomization.
Randomization, Allocation Concealment and blinding Patients will be randomly allocated into one of 2 parallel groups (40 in each group) based on sample size. Randomization will be achieved using computer-generated random numbering of each study patient. Allocation concealment will be insured using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE), prepared by a researcher not involved in patient recruitment or outcome assessment. The block tray and necessary equipment will be prepared by an independent anesthesiologist not involved in patient assessment. The patient and researcher who collects the data after the block will be blinded to the study group. All study outcomes will be evaluated by a dedicated anesthesiologist who will be blinded to the group allocation.Patients will be randomized into 2 groups.
Group (S) patients who will receive sacral erector spinae plane block. Group (G) patients who will receive pericapsular nerve group block. Anesthesia procedure
- The study protocol, sacral erector plane block, PENG block and the numerical pain rating score (NPRS) will be explained to each patient during the preanesthetic counselling. The (NPRS) is 11-point numeric scale ranges from 0 to 10, (where score 0 =no pain and 10 =worst pain imaginable) .
- . Before the participants will be admitted in this study, the purpose and nature of the study, as well as the risk-benefit assessment will be explained to them. An informed consent will be obtained from participants. Patients will fast for about 6 to 8 hours for solid meals, for 4 hours for non-clear liquids and for 2 hours for clear liquids before surgery .
Anesthetic technique
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ages from 50 to 90 years of either gender, with diagnosis of intracapsular neck of femur fracture scheduled for elective hip hemiarthroplasty • Patients with an American Society of Anesthesiologists (ASA) physical status I to III.
排除标准
- •• Patient refusal.
- •Allergy to local anesthetics and patient with infection at the injection site of block
- •Patient with contraindication to spinal anesthesia.
- •Coagulopathy as INR≥1.5 or platelets ≤80*103 / microliter)
- •Patients with body mass index>35 kg / m2
- •Patients with peripheral neuropathy or diabetic neuropathy
- •Patients receiving opioids for chronic analgesic therapy (cancer, addiction).
- •Cognitive impairment preventing pain scoring.
- •Chronic renal failure requiring dose modification.
- •Bilateral hip fracture or previous ipsilateral hip surgery
研究组 & 干预措施
S group
This group will receive sacral erector spinae plane block in the operating room, after spinal anesthesia and before skin incision, when the patient will be in the lateral decubitus position, aseptic conditions will be provided for the block.
干预措施: Sacral erector spinae plane block (Procedure)
G group
This group will receive PENG Block in the operating room, after spinal anesthesia and before skin incision. Patients will be placed in the supine position, aseptic conditions will be provided for the block.
干预措施: PENG block (Procedure)
结局指标
主要结局
Numerical pain rating score (NPRS) after surgery at rest.
时间窗: At twelve hours postoperatively
Numerical Pain Rating Scale (NPRS) is a subjective measure where patients rate their pain on an 11-point numerical scale. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores indicate a worse outcome (greater pain intensity).
次要结局
- Numerical Pain Rating Scale(NPRS) during movement and at rest in 24 h after surgery at (2,4,6,8,12,18,24)(At 2, 4, 6, 8, 12, 18, and 24 hours postoperatively.)
- Cumulative morphine consumption in 24 hours in mg(During the first 24 hours postoperatively)
- Time for first rescue analgesia (hours), standard rescue analgesia (Morphine PCA or IV (dose specified)(In the first 24 hours postoperatively)
- Intraoperative opioids consumption.(Intraoperative peroid)
- Inability to perform physiotherapy at 24 hours.(At 24 hours postoperatively.)
- Delirium assessment (CAM score), a diagnosis of delirium is made if the patient has both (Acute onset and fluctuating course) and (Inattention), plus either (Disorganized thinking) or (Altered level of f consciousness) 20(Twice daily (every 12 hours) for the first 72 hours postoperatively.)
- The incidence of block-related adverse events (ie, vascular puncture, LA toxicity).(For Vascular Puncture: "Intraoperatively, during the performance of the nerve block. For LA Toxicity (LAST): "From the time of injection until 60 minutes post-procedure.)
- Incidence of quadriceps motor block at 3,6,12,24 hours postoperatively(At 3, 6, 12, and 24 hours postoperatively.)
- Opioid related side effects (ie, nausea, vomiting, urine retention, respiratory depression)(From the time of the first dose up to 24 hours post-administration.)
- Length of stay in hospital.(From the day of surgery until hospital discharge, assessed up to 30 days.)
研究者
Mohamed Ahmed Hamed
professor of anesthesia, Surgical ICU and Pain management , Faculty of Medicine, Fayoum University
Fayoum University Hospital