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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kerollos Moneer Neseem Mikhael, MD
- 전화번호: 00201288549959
- 이메일: Kmnmk87@med.bsu.edu.eg
연구 장소
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Banī Suwayf, 이집트, 62515
- Beni-Suef University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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.
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Score on Movement at 12 Hours
기간: 12 hours after the end of surgery
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Scores at Rest and Movement at Specified Time Points
기간: 30 minutes, 2 hours, 6 hours, 24 hours, and 48 hours after surgery
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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
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Cumulative Opioid Consumption in the First 24 Hours
기간: First 24 hours postoperatively
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Total dose of intravenous pethidine (meperidine) administered as rescue analgesia in milligrams (mg). |
First 24 hours postoperatively
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Time to First Rescue Analgesic Request
기간: Up to 48 hours postoperatively
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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
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Quadriceps Motor Function (Knee Extension Strength)
기간: At 6, 12, and 24 hours postoperatively
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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
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Incidence of Block-Related Complications and Opioid-Related Adverse Events
기간: Up to 48 hours postoperatively
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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
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Length of Hospital Stay
기간: From date of surgery until hospital discharge (up to approximately 30 days)
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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)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- FMBSUREC/07062026b/ Mikhael
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
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