Fayoum University Hospital
El Fayoum Qesm, Fayoum Governorate, 63514, Egypt
NCT Number: NCT06369948
Patients undergoing hip hemiarthroplasty can benefit significantly from regional anesthesia in terms of pain management and recovery . There is a wide range of regional anesthetic techniques. The most common in this anatomical region and those with the greatest published research are fascia iliac block, lumbar plexus block, and femoral nerve block . Alternative methods include lateral femoral cutaneous nerve and selective obturator nerve infiltration blocks. Novel techniques, including local infiltration analgesia and quadratus lumborum block, have been reported.
While femoral nerve and lumbar plexus blocks are two common opioid-sparing regional anesthetic procedures that are successful, they come with a risk of undesired lower limb muscle weakness . On the other hand, the fascia iliac block does not always offer sufficient pain relief following hip surgery. The important landmarks targeted on the hip joint branches from the femoral nerve and the auxiliary obturator nerve may now be identified thanks to a recent anatomical study on hip innervation .
This led to the discovery of a novel localized anesthetic treatment termed pericapsular nerve group block (PENG), which blocks these nerves to target the hip's anterior capsule. The PENG block has been suggested as a successful motor-sparing block for hip hemiarthroplasty . The objective of the current study is to evaluate the efficacy of the pericapsular nerve group block (PENG) for the reduction of opioid consumption and management of postoperative pain after hip hemiarthroplasty.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
El Fayoum Qesm, Fayoum Governorate, 63514, Egypt
This study will be performed in the Fayoumi University Hospital after approval by the local Institutional Ethics Committee and local institutional review board. The study design will be a double-blinded, randomized controlled study trial. The researcher will inform the participants about the objectives of the study, the examination, and the investigation that will be done. Also, the confidentiality of their information and their right not to participate in the study. Written informed consent will be obtained from all patients included in the study.
The study will include 60 patients who will undergo elective hip hemiarthroplasty. Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block.
Pericapsular Nerve Group (PENG) Block (P group) includes 30 patients who will receive a PENG block.
Control group (C group) includes 30 patients who will not receive a PENG block. A full medical history will be taken from the included patients, including demographic data (age, body mass index , weight, gender), general medical history (Diabetes, Hypertension, medication use), anesthesia, and previous surgeries. The patients' fasting durations will be 8 hours for solids and 2 hours for clear liquids. All patients will be assessed Preoperative for VAS score. All patients were monitored by 5 lead ECG, pulse oximetry, non-invasive blood pressure and an intravenous access will be established.
The technique of spinal anesthesia will be standardized for all patients, an attending anesthesiologist will use a 25-gauge Quincke spinal needle (Spinocan, B. Braun Melsungen AG, Germany) to induce spinal anesthesia in the L3/4 or L4/5 vertebral interspace. Throughout the course of the trial, the attending anesthesiologist will chose the dosages of 0.5% hyperbaric bupivacaine (10 to 15 mg) and fentanyl (15 mcg), aiming for a sensory block at the T4 level. The patient will be placed in the sitting or left lateral position while the spinal injection is given over a period of 15 to 30 seconds. Three minutes following the spinal injection, the sensory block was evaluated with a cold and pinprick test. The patient will be placed in a supine position, neutral-head resting posture in the operating area as standard monitors that mentioned before .
Data will be gathered, coded to make data manipulation easier, double-entered into Microsoft Access, and will be analyzed using SPSS software version 22 running on Windows 7 (SPSS Inc., Chicago, IL, USA). Simple descriptive analysis will use percentages and numbers for qualitative data, arithmetic means for measuring central tendency, and standard deviations for quantifying dispersion for parametric quantitative data.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The PENG block will be performed with the patient in the supine position. A linear high-frequency ultrasound probe (GE LOGIQ/P7 ultrasound, korea/ L6-12RS probe) is initially placed in a transverse plane over the anterior inferior iliac spine (AIIS); the probe is turned slightly medial until the hyperechoic continuous shadow of the iliopubic eminence (IPE). The target will be the plane between the psoas tendon and pubic ramus. The skin puncture site will be anesthetized using lidocaine 2% after skin disinfection and draping. A 22-gauge, 100 mm echogenic needle (Spinocan, B. Braun Melsungen AG, Germany) will be inserted in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, 25 mL of the local anesthetic solution (bupivacaine 0.5%) was injected in 5 mL increments while observing for adequate fluid spread in this plane.
elective hip hemiarthroplasty without receiving a PENG block.
bupivacaine 0.5% injection
Time frame: from zero hour and at time intervals: 30 minutes, 1hour, 3 hour, 6 our., 12 hour, 24 hour, 48 hour, and 36 hour after block administration
total dose of any opioid drug used for pain control postoperative
Time frame: at time intervals: 30 minutes, 1hour, 3 hour, 6 hour, 12 hour, 24 hour, 48 hour, and 72 hour. after block administration
Degree of pain as measured by fascial expression with rang from 0 for no pain to 10 for sever pain
Time frame: first 24 hour after block administration
time taken till first dose of opioid drugs to control pain after 24 hour of block administration
Time frame: 1 year
time taken until the participant able to perform physiotherapy in first 24 hour after block administration
Time frame: 1 year
side effects of opioids used for pain control after surgery
Time frame: 1 year
time of stay of the participant in the hospital after surgery and block administration
Time frame: 1 year
complication of local anesthetic drug injected in the procedure
Fayoum University Hospital
Other
Quality Of Recovery After Pericapsular Nerve Group (PENG) Block For Hip Hemiarthroplasty Under Spinal Anesthesia: A Prospective, Double-Blinded, Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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