Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Lumbar Erector Spinae Plane Block Versus Pericapsular Nerve Group (PENG) Block in Patients With Fracture Neck of Femur Undergoing Hip Surgery: A Randomized, Double-Blind, Controlled Trial
The purpose of this clinical trial is to compare two different nerve block techniques-the Pericapsular Nerve Group (PENG) block and the Lumbar Erector Spinae Plane Block (L-ESPB)-for managing pain after hip fracture surgery in elderly patients.
Hip fractures are common in older adults and often cause significant pain. Managing this pain effectively helps patients recover faster and move around sooner after surgery. Traditional pain relief options include nerve blocks and strong pain medications (opioids). However, opioids can cause unwanted side effects like nausea and drowsiness, while some traditional nerve blocks can weaken the leg muscles, making early walking difficult.
Nerve blocks inject a local anesthetic (numbing medication) around specific nerves or within muscle layers to temporarily block pain signals:
- PENG Block: Targets the specific sensory nerves supplying the front of the hip joint while minimizing leg muscle weakness.
- Lumbar ESPB: Injects numbing medication near the lower spine to block pain signals coming from the hip region.
Participants in this study will include adults aged 60 and older undergoing hip surgery for a femoral neck fracture under spinal anesthesia. Participants will be randomly assigned (like flipping a coin) to receive either the PENG block or the Lumbar ESPB before their surgery. Both blocks are performed under ultrasound guidance to ensure precise medication placement.
Researchers will compare:
- Pain levels at rest and during movement over the first 48 hours after surgery.
- The total amount of additional pain medication (opioids) required.
- Leg muscle (quadriceps) strength after surgery.
- Any side effects or complications, as well as the overall length of hospital stay.
The findings from this study will help doctors determine which nerve block provides better pain relief while preserving leg strength, aiding in safer and faster recovery for elderly patients after hip surgery.
調査の概要
状態
詳細な説明
BACKGROUND AND RATIONALE:
Hip fractures in elderly patients are associated with significant morbidity, prolonged hospitalization, and functional decline. Effective perioperative analgesia is crucial for early recovery. While systemic opioids and conventional nerve blocks (such as femoral or fascia iliaca blocks) provide pain relief, they are often limited by quadriceps weakness, opioid-related side effects, and delayed mobilization.
The Pericapsular Nerve Group (PENG) block targets the articular branches of the femoral, obturator, and accessory obturator nerves supplying the anterior hip capsule, offering motor-sparing analgesia. The lumbar erector spinae plane block (L-ESPB) is a paraspinal fascial plane block allowing craniocaudal local anesthetic spread to dorsal and ventral rami. Head-to-head evidence comparing L-ESPB and PENG blocks in patients with femoral neck fractures undergoing hip surgery remains limited.
STUDY PROTOCOL & INTERVENTIONS:
This prospective, randomized, double-blind, parallel-group clinical trial evaluates elderly patients (age ≥60 years, ASA II-III) undergoing hip surgery (hemiarthroplasty or total hip arthroplasty) under spinal anesthesia.
Participants are randomized in a 1:1 ratio to receive either:
- Group P: Ultrasound-guided PENG block using 20-25 mL of 0.25% bupivacaine.
- Group E: Ultrasound-guided L-ESPB at L3/L4 level using 25-30 mL of 0.25% bupivacaine.
Blocks are performed 20 minutes preoperatively by a dedicated anesthetist not involved in outcome assessment. All patients receive standardized intraoperative spinal anesthesia and postoperative multimodal systemic analgesia (scheduled IV/oral paracetamol with IV pethidine as rescue analgesia). Pain scores at rest and on movement, cumulative 24-hour opioid consumption, quadriceps strength (MRC scale), block-related complications, and length of hospital stay will be evaluated.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kerollos Moneer Neseem Mikhael, MD
- 電話番号：00201288549959
- メール：Kmnmk87@med.bsu.edu.eg
研究場所
-
-
-
Banī Suwayf、エジプト、62515
- Beni-Suef University Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 60 years or older.
- Unilateral fracture neck of femur scheduled for hip surgery (hemiarthroplasty or total hip arthroplasty) under spinal anesthesia (with or without light sedation).
- American Society of Anesthesiologists (ASA) physical status II-III.
- Ability to understand and use Numeric Rating Scale (NRS) pain scoring and to provide informed consent (or availability of a legally authorized representative according to local regulations).
Exclusion Criteria:
- Patient refusal to participate.
- Coagulopathy (platelet count < 100,000/µL, INR > 1.4) or ongoing therapeutic anticoagulation that precludes deep peripheral or neuraxial blocks per current guidelines.
- Infection at the injection site, systemic sepsis, or hemodynamic instability.
- Pre-existing significant neurological deficit in the involved lower limb, advanced peripheral neuropathy, or cognitive impairment precluding reliable pain assessment.
- Known allergy or hypersensitivity to amide local anesthetics or study medications.
- Severe chronic opioid use (defined as > 30 mg oral morphine equivalent daily for > 3 months).
- Body Mass Index (BMI) > 35 kg/m² if considered to significantly hinder ultrasound visualization, at investigator discretion.
- Prior hip surgery on the same side or severe anatomical hip deformity affecting block performance.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：PENG Block
Patients receive an ultrasound-guided Pericapsular Nerve Group (PENG) block preoperatively using 20-25 mL of 0.25% bupivacaine (50-62.5 mg) deposited in the fascial plane between the iliopsoas tendon and pubic ramus near the iliopubical eminence (IPE). Standard spinal anesthesia and postoperative multimodal systemic analgesia are administered. |
Ultrasound-guided nerve block performed 20 minutes preoperatively in the supine position. A 22G echogenic needle is directed in-plane lateral-to-medial to target the fascial plane deep to the iliopsoas tendon. Following negative aspiration and hydrodissection (2-3 mL saline), 20-25 mL bupivacaine 0.25% (or 15-20 mL in frail/small patients) is injected in 3-5 mL aliquots.
他の名前：
|
|
アクティブコンパレータ：Lumbar ESPB
Patients receive an ultrasound-guided Lumbar Erector Spinae Plane Block (L-ESPB) preoperatively at the L3 or L4 transverse process level using 25-30 mL of 0.25% bupivacaine (62.5-75 mg) deposited deep to the erector spinae muscle. Standard spinal anesthesia and postoperative multimodal systemic analgesia are administered. |
Ultrasound-guided fascial plane block performed 20 minutes preoperatively in the lateral decubitus or sitting position. A 22G echogenic needle is advanced in-plane cranial-to-caudal to contact the L3 or L4 transverse process. Following negative aspiration and hydrodissection confirming muscle lifting, 25-30 mL bupivacaine 0.25% is injected in 3-5 mL aliquots.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Score on Movement at 12 Hours
時間枠：12 hours after the end of surgery
|
Pain intensity assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain is evaluated during gentle passive leg movement (flexion or rotation) of the operated limb. |
12 hours after the end of surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Scores at Rest and Movement at Specified Time Points
時間枠：30 minutes, 2 hours, 6 hours, 24 hours, and 48 hours after surgery
|
Pain intensity measured using the Numeric Rating Scale (NRS 0-10, where 0 = no pain and 10 = worst imaginable pain) at rest and during gentle passive movement of the operated limb. |
30 minutes, 2 hours, 6 hours, 24 hours, and 48 hours after surgery
|
|
Cumulative Opioid Consumption in the First 24 Hours
時間枠：First 24 hours postoperatively
|
Total dose of intravenous pethidine (meperidine) administered as rescue analgesia in milligrams (mg). |
First 24 hours postoperatively
|
|
Time to First Rescue Analgesic Request
時間枠：Up to 48 hours postoperatively
|
Duration of time measured in hours from the end of surgery until the patient requests the first dose of rescue IV pethidine. |
Up to 48 hours postoperatively
|
|
Quadriceps Motor Function (Knee Extension Strength)
時間枠：At 6, 12, and 24 hours postoperatively
|
Evaluation of ipsilateral quadriceps muscle strength using the Medical Research Council (MRC) scale, ranging from 0 (no movement) to 5 (normal strength). Motor weakness is defined as an MRC grade ≤ 3/5. |
At 6, 12, and 24 hours postoperatively
|
|
Incidence of Block-Related Complications and Opioid-Related Adverse Events
時間枠：Up to 48 hours postoperatively
|
Percentage of participants experiencing adverse events including postoperative nausea and vomiting (PONV), pruritus, urinary retention, hypotension, bradycardia, signs of local anesthetic systemic toxicity (LAST), hematoma, injection site infection, neurological deficit/nerve injury, or falls. |
Up to 48 hours postoperatively
|
|
Length of Hospital Stay
時間枠：From date of surgery until hospital discharge (up to approximately 30 days)
|
Duration of time from surgery completion until discharge from the hospital, measured in total days. |
From date of surgery until hospital discharge (up to approximately 30 days)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- FMBSUREC/07062026b/ Mikhael
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual de-identified participant data underlying the published primary and secondary results (including demographic data, baseline characteristics, NRS pain scores, cumulative opioid consumption, quadriceps motor strength scores, and adverse events) will be made available upon reasonable request to qualified academic researchers.
IPD 共有時間枠
Data will become available starting 6 months following publication of the primary manuscript in a peer-reviewed journal and will remain accessible for up to 3 years.
IPD 共有アクセス基準
Data will be shared with researchers whose proposed use has been approved by an independent review committee or the principal investigator to achieve the aims of an approved scientific proposal. Requests should be directed to the Principal Investigator (Dr. Kerollos Moneer Neseem Mikhael) via email. A signed Data Use Agreement (DUA) may be required.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。