- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07597551
PENG vs. Femoral Nerve Block for Pain Control in Hip Surgery
Comparative Study Between Continous Ultrasound Guided Pericapsular Nerve Group (PENG) Block Versus Femoral Nerve Block For Perioperative Pain Control In Hip Surgeries
연구 개요
상세 설명
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
• The primary outcome will measure: The postoperative pain score, assessed using an 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable), at 0, 1, 2, 6, 12 and 24 hours postoperative (day 0) at rest and during movement. 6
• Secondary outcomes will include:
- Postoperative quadriceps strength, and physiotherapy compliance assessed using the knee extension test and the Oxford muscle strength grading scale grouped as intact [5/5], reduced [1-4/5], and absent [0/5] in the recovery unit and on postoperative day 0.
- Postoperative opiate consumption, reported for the subsequent 3 postoperative days.
- Postoperative complications, classified according to the Clavien- Dindo classification.
- Length of hospital stay, measured in days from the day of surgery to the day of discharge.
Patient-reported outcomes (PROMs) assessed on postoperative day
1 using the Patient-Reported Outcomes Measurement Information System (PROMIS) item banks for depression and pain interference, the Brief Pain Inventory (BPI), and the Quality of Recovery (QoR- 15) questionnaire.
- Patient satisfaction with pain management, evaluated by the APS on first postoperative day. Patients will also be asked to recall the time of block resolution, defined as the return of motor function if initially impaired and/or the recovery of sensation in the blocked area
All patients will be subjected to the following:
Preoperative assessment:
All patients will undergo a detailed pre-anesthetic check-up, including: 1.1. Detailed history taking including:
- Personal history; age, gender, residence, occupation, and special habits. 7
- Relevant comorbidities as hypertension, coronary disease, heart failure, chronic obstructive pulmonary disease and diabetes mellitus.
- Mechanism of injury
- History of any medical condition or previous hospital admission 1.2. Full clinical examination: 1.2.1. General examination including:
- Vital signs: pulse, blood pressure, capillary filling time, respiratory rate and temperature.
- Assessment of body mass index (BMI) 1.2.2. Systemic examination including:
- Cardiovascular System: For detection of any abnormal heart sounds or murmurs.
- Respiratory System: For detection of any abnormal breath sound, and respiratory distress.
- Gastrointestinal Tract (GIT) and Abdomen: Presence of organomegaly or ascites.
- Central Nervous System (CNS) and Musculoskeletal System:
Assessment of pupillary reaction, examination of motor system including power, tone and reflexes. 1.3. Routine laboratory investigations:
- Complete blood count (CBC).
- Random blood sugar.
- Kidney function tests.
- Liver function tests
- Operative The Pericapsular Nerve Group (PENG) block and the Femoral Nerve Block (FNB) will be performed using ultrasound guidance with a 8 high-frequency (10-12 Hz) 38-mm linear ultrasound transducer (Imagic Agile, Peachtree, Georgia). All blocks will be administered by an independent experienced anesthetist who has demonstrated proficiency in performing both PENG and FNB blocks.
Prior to the nerve block procedure:
The following baseline measurements will be recorded by the administering anesthetist and documented for the study investigators: baseline vital parameters (pulse, blood pressure, respiratory rate), baseline pain score using the Numeric Rating Scale (NRS), and a baseline assessment of quadriceps strength using the Oxford muscle strength grading scale (if feasible given the patient's condition).
During the nerve block procedure:
The following parameters will be noted:
- Allocated Block: The specific nerve block administered (PENG or FNB).
- Procedural Duration: Defined as the time from skin puncture to the completion of local anesthetic injection and catheter insertion.
- Pain on Injection: Patient-reported pain during the block administration using the NRS (0-10).
- Technical Difficulties: Any challenges encountered during block placement, such as multiple needle passes , difficulty visualizing anatomical structures, difficulty in insertion ofcatheter.
Following block administration:
9 The anesthetist will assess for the onset of sensory and motor blockade in the anterior thigh and knee and assessing for any quadriceps weakness using the Oxford scale. These findings will be documented and handed over to the investigators. 3. Postoperative Postoperatively, rescue analgesia will be available in the form of intravenous morphine and boluses of local anesthesia in the infusion catheter administered on patient demand or if the Numeric Rating Scale (NRS) pain score is ≥ 4 Measurements The following measurements will be recorded for each participant throughout the study period:
- Baseline Demographic Characteristics: Age, sex, Body Mass Index (BMI), and ASA physical status will be documented prior to the surgical procedure.
Perioperative Hemodynamic Data: Heart rate and Mean Arterial
Pressure will be measured and recorded at the following time points:
upon arrival in the Post-Anesthesia Care Unit (PACU), and at 1, 2, 4, 8, 12, 18, 24, 48 hours postoperatively.
- Postoperative Pain Levels: Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at rest and during active movement (specifically during the quadriceps strength test). Assessments will be performed and recorded upon arrival in the PACU, and at 1, 2, 4, 8, 12,24, 48 hours postoperatively. For the purpose of rescue analgesia administration, an NRS score of ≥ 4 will indicate the need for intervention.
- Time to First Request for Opioid Analgesiapost operative: The time to the first patient-initiated request for opioid rescue medication will be recorded. The dose of the intravenous morphine administered will be documented.
Assessment of Sensory and Motor Block:
• Sensory Block: Sensory function in the (anterior thigh) will be assessed using pinprick and categorized into three grades: 0 (normal sensation), 1 (decreased sensation), and 2 (absent sensation). This assessment will be performed immediately after block placement in the preoperative area and the resolution of the block will be noted by the patient and recorded. 11
- 7. • Motor Block (Quadriceps Strength): Motor function of the quadriceps muscle will be assessed using the Oxford muscle strength grading scale (0-5) immediately after block placement in the preoperative area and at the predefined postoperative time points (recovery unit/day 0 and postoperative day 1). The time to full motor recovery (Oxford scale 5/5) will also be recorded. Degree of Patient Satisfaction: Patient satisfaction with their overall pain management will be assessed on postoperative day 1 using a 5- point Likert scale: (1 = highly satisfied, 2 = satisfied, 3 = neither satisfied nor unsatisfied, 4 = not satisfied, 5 = highly not satisfied) , physiotherapy compliance. Adverse Events: Any undesirable side effects occurring within the first 24 postoperative hours (e.g., nausea, vomiting, bradycardia, hypotension, pruritus, respiratory depression, signs of local anesthetic systemic toxicity) will be documented, along with the treatment administered.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mohamed I Swera, Master
- 전화번호: 00201005818338
- 이메일: mohamedswera86@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion 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:
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.
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 |
|---|---|
|
실험적: PENG block group
Participants in this group will receive a preoperative, ultrasound-guided Pericapsular Nerve Group (PENG) block.
Under sterile conditions and ultrasound guidance (curvilinear or linear probe), the needle will be inserted in-plane to target the facial plane between the psoas tendon and the pubic ramus.
A volume of 20-25 mL of 0.25% Bupivacaine will be injected following negative aspiration
|
Regional anesthesia technique involving the injection of local anesthetic into the myofascial plane between the psoas muscle and the iliopubic eminence.
다른 이름들:
|
|
활성 비교기: Femoral nerve block group
Participants in this group will receive a preoperative, ultrasound-guided Femoral Nerve Block (FNB).
Using a linear probe, the femoral nerve will be identified lateral to the femoral artery and deep to the fascia iliaca.
A volume of 20-25 mL of 0.25% Bupivacaine will be injected to achieve circumferential spread around the nerve trunk
|
Regional anesthesia technique involving the injection of local anesthetic deep to facia iliaca and lateral to femoral artery circulating femoral nerve trunk.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Visual Analog Scale (VAS) Score for Pain at 24 Hours.
기간: 24 hours postoperatively.
|
A scale from 0 to 10 (0 = no pain, 10 = worst imaginable pain).
Patients will be asked to rate their pain level at rest.
|
24 hours postoperatively.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quadriceps Muscle Strength
기간: 6, 12, and 24 hours post-op.
|
Assessment of muscle power using the Medical Research Council (MRC) scale (range 0-5).
|
6, 12, and 24 hours post-op.
|
|
Total Opioid Consumptiont
기간: First 3 days
|
Total cumulative dose of rescue analgesia required by the patient.
|
First 3 days
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Taghreed Saker, MD, Benha University
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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