Quality Of Recovery After Pericapsular Nerve Group (PENG) Block For Hip Hemiarthroplasty Under Spinal Anesthesia
- Conditions
- Hip Hemiarthroplasty
- Interventions
- Procedure: elective hip hemiarthroplasty without receiving a PENG block.Procedure: Pericapsular Nerve Group (PENG) Block
- Registration Number
- NCT06369948
- Lead Sponsor
- Fayoum University Hospital
- Brief Summary
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.
- Detailed Description
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.
- For quantitative data: Independent samples t-test will be used to compare quantitative measures between two independent groups Paired t-test will be used to compare two dependent quantitative data.
* For qualitative data The Chi-square test will be used to compare two of more than two qualitative groups.
* Sensitivity and specificity test for testing a new test with ROC curve "Receiver Operating Characteristic".
* The P-value\< 0.05 will be considered statistically significant.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
-
- patients 18 years old or older with ASA physical status 1-3, patients who had no contraindications for spinal anesthesia, and patients undergoing elective surgery.
- Patients with ASA physical status 4 or above.
- Pre-existing anatomical or neurological deficits in the lower extremity.
- Intolerance or allergy to local anesthetics.
- Narcotic dependency.
- Coagulopathy or using antiplatelet or anticoagulant medications.
- Neuromuscular diseases.
- Psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression).
- Systemic infections or infections at site of injection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pericapsular Nerve Group (PENG) Block (P group) bupivacaine 0.5% injection Patients who will undergo elective hip hemiarthroplasty and receive the Pericapsular Nerve Group (PENG) block postoperatively. Control group (C group) elective hip hemiarthroplasty without receiving a PENG block. Patients who will undergo elective hip hemiarthroplasty without receiving a PENG block. Pericapsular Nerve Group (PENG) Block (P group) Pericapsular Nerve Group (PENG) Block Patients who will undergo elective hip hemiarthroplasty and receive the Pericapsular Nerve Group (PENG) block postoperatively.
- Primary Outcome Measures
Name Time Method Total opioid consumption post operative 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
- Secondary Outcome Measures
Name Time Method 3) Time to first opioid use first 24 hour after block administration time taken till first dose of opioid drugs to control pain after 24 hour of block administration
7) Complications of local anesthetic toxicity 1 year complication of local anesthetic drug injected in the procedure
2) a Visual Analogue Scale (VAS) ranging from zero (no pain) to 10 (severe pain) for dynamic and static pain 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
6) Total length stay of hospital 1 year time of stay of the participant in the hospital after surgery and block administration
4) Ability to perform physiotherapy 1 year time taken until the participant able to perform physiotherapy in first 24 hour after block administration
5) Opioid-related side effects. 1 year side effects of opioids used for pain control after surgery
Trial Locations
- Locations (1)
Fayoum University Hospital
🇪🇬Madīnat Al Fayyūm, Fayoum Governorate, Egypt