- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07903740
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty (PENG-LFCN-EEG)
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
This prospective, randomized controlled trial aims to evaluate the effects of combined pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks on intraoperative anaesthetic consumption and electroencephalographic (EEG)-derived anaesthetic depth in patients undergoing elective total hip arthroplasty.
A total of 50 adult patients will be randomly allocated to two groups: combined PENG and LFCN blocks followed by general anaesthesia, or general anaesthesia alone. Anaesthetic depth will be monitored using the SedLine EEG monitoring system.
The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include remifentanil consumption, EEG-derived parameters including Patient State Index (PSI) and suppression ratio, haemodynamic variables, and recovery characteristics.
The study aims to determine whether combined regional blocks reduce anaesthetic requirements while maintaining adequate EEG-guided anaesthetic depth.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Total hip arthroplasty is frequently associated with significant nociceptive stimulation during surgery. Regional anaesthesia techniques, including the pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, may reduce intraoperative nociceptive input and consequently decrease anaesthetic and opioid requirements.
This prospective, randomized controlled trial will include 50 patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective total hip arthroplasty.
Patients will be randomly assigned in a 1:1 ratio to either an intervention group receiving combined ultrasound-guided PENG and LFCN blocks before general anaesthesia or a control group receiving general anaesthesia without preoperative regional blocks.
General anaesthesia will be administered using a standardized EEG-guided protocol. During induction, propofol will be titrated to achieve a target Patient State Index (PSI) of 25-50, as monitored by the SedLine system. Following tracheal intubation, anaesthesia will be maintained with sevoflurane, with continuous EEG monitoring to maintain the target PSI range.
The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include total remifentanil consumption, EEG-derived anaesthetic depth parameters, suppression ratio measurements, the occurrence and duration of burst suppression, intraoperative haemodynamic variables, and postoperative recovery characteristics.
By comparing anaesthetic consumption and EEG-derived parameters between the two groups, this study aims to evaluate the effects of combined PENG and LFCN blocks on intraoperative anaesthetic requirements and EEG-guided anaesthetic depth during total hip arthroplasty.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: AYSE SENCAN, M.D Anaesthesiology Specialist
- Telefonnummer: +905078313235
- E-post: draysesencan@gmail.com
Studieorter
-
-
Kocaeli
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Köseköy, Kocaeli, Turkiet (Türkiye), 41100
- Kocaeli City Hospital
-
Kontakt:
- AYSE SENCAN, M.D Anaesthesiology Specialist
- Telefonnummer: +905078313235
- E-post: draysesencan@gmail.com
-
Kontakt:
- Ayse Zeynep Turan Civraz, Associated Professor
- Telefonnummer: +905054695850
- E-post: ayse.zeynep@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective primary total hip arthroplasty
- Undergoing general anaesthesia
- Provision of written informed consent to participate in the study
Exclusion Criteria:
- Known allergy to local anaesthetics
- Contraindications to PENG or LFCN block
- Infection at the planned block injection site
- Coagulopathy or anticoagulant therapy considered unsuitable for regional anaesthesia
- Chronic opioid use
- Significant neurological disorders that may interfere with EEG assessment
- Cognitive impairment preventing comprehension of the study protocol or provision of informed consent
- Inability to perform SedLine monitoring
- Inability to obtain written informed consent
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: PENG + LFCN Block Group
Patients in this group will receive ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks before general anaesthesia. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. |
Ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks will be performed before induction of general anaesthesia. Both blocks will be administered as part of a combined regional anaesthesia technique to provide perioperative analgesia during total hip arthroplasty. |
|
Aktiv komparator: No Intervention Group
Patients in this group will undergo general anaesthesia without preoperative peripheral nerve blocks. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. |
General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. Remifentanil will be administered intraoperatively according to a standardized anaesthetic protocol. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intraoperative Sevoflurane Consumption (ml/h)
Tidsram: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
|
Intraoperative sevoflurane consumption will be recorded in millilitres (mL) using the anaesthesia workstation. Hourly sevoflurane consumption will be calculated by dividing the total consumption by the duration of sevoflurane administration in hours. |
From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Weight-Adjusted Intraoperative Remifentanil Consumption (µg/kg/h)
Tidsram: From initiation to discontinuation of remifentanil infusion during general anaesthesia.
|
Weight-adjusted hourly remifentanil consumption will be determined by dividing the total administered remifentanil dose (µg) by patient body weight (kg) and the duration of remifentanil infusion in hours. |
From initiation to discontinuation of remifentanil infusion during general anaesthesia.
|
|
Mean Intraoperative Patient State Index (PSI)
Tidsram: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
|
The mean Patient State Index (PSI) during sevoflurane anaesthesia will be determined using continuous EEG monitoring data obtained from the SedLine system. |
From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
|
|
Mean Intraoperative Suppression Ratio (SR)
Tidsram: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
|
The mean suppression ratio (SR) will be determined using continuous EEG monitoring data obtained from the SedLine system during sevoflurane anaesthesia and expressed as a percentage (%). |
From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
|
|
Percentage of Time With Suppression Ratio Above 5%
Tidsram: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
|
The percentage of time during which the suppression ratio (SR) exceeds 5% will be determined using continuous EEG monitoring data obtained from the SedLine system during sevoflurane anaesthesia. |
From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
|
|
Time to Extubation (min)
Tidsram: From discontinuation of sevoflurane administration until tracheal extubation.
|
Time to extubation will be defined as the interval between discontinuation of sevoflurane administration and removal of the endotracheal tube, expressed in minutes. |
From discontinuation of sevoflurane administration until tracheal extubation.
|
|
Postoperative Richmond Agitation-Sedation Scale (RASS) Score
Tidsram: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
|
Postoperative sedation and agitation will be assessed using the Richmond Agitation-Sedation Scale (RASS) at 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU). Scores range from -5 (unarousable) to +4 (combative), with 0 indicating an alert and calm state. |
At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
|
|
Postoperative Nursing Delirium Screening Scale (NuDESC) Score
Tidsram: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
|
Postoperative delirium-related symptoms will be assessed using the Nursing Delirium Screening Scale (NuDESC) at 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU). Scores range from 0 to 10, with higher scores indicating more pronounced delirium-related symptoms. |
At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
- Pawar N, Barreto Chang OL. Burst Suppression During General Anesthesia and Postoperative Outcomes: Mini Review. Front Syst Neurosci. 2022 Jan 7;15:767489. doi: 10.3389/fnsys.2021.767489. eCollection 2021.
- Carella M, Bugada D, Van de Velde M, Beloeil H, Albrecht E, Lavandhomme P, Raeder J, Joshi GP; PROSPECT Working Group of the European Society of Regional Anesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2026 Jul 20. doi: 10.1111/anae.70299. Online ahead of print.
- Ozturk L, Kesimci E, Albayrak T, Kanbak O. Bispectral index-guided general anaesthesia in combination with interscalene block reduces desflurane consumption in arthroscopic shoulder surgery: a clinical comparison of bupivacaine versus levobupivacaine. BMC Anesthesiol. 2015 Jul 21;15:104. doi: 10.1186/s12871-015-0087-8.
- Musizza B, Ribaric S. Monitoring the depth of anaesthesia. Sensors (Basel). 2010;10(12):10896-935. doi: 10.3390/s101210896. Epub 2010 Dec 3.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PENG-LFCN-THA-2026
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