An interventional study of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block and EEG-Guided General Anaesthesia in Total Hip Arthroplasty (THA), sponsored by Kocaeli City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Kocaeli City Hospital · Not applicable, Interventional, and Treatment
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.
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.
Kocaeli City Hospital is the lead sponsor of 43 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block
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.
Procedure: EEG-Guided General Anaesthesia
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.
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.
Intraoperative Sevoflurane Consumption (ml/h)
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.
Time frame: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Weight-Adjusted Intraoperative Remifentanil Consumption (µg/kg/h)
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.
Time frame: From initiation to discontinuation of remifentanil infusion during general anaesthesia.
Mean Intraoperative Patient State Index (PSI)
The mean Patient State Index (PSI) during sevoflurane anaesthesia will be determined using continuous EEG monitoring data obtained from the SedLine system.
Time frame: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Mean Intraoperative Suppression Ratio (SR)
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 (%).
Time frame: 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%
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.
Time frame: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Time to Extubation (min)
Time to extubation will be defined as the interval between discontinuation of sevoflurane administration and removal of the endotracheal tube, expressed in minutes.
Time frame: From discontinuation of sevoflurane administration until tracheal extubation.
Postoperative Richmond Agitation-Sedation Scale (RASS) Score
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.
Time frame: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
Postoperative Nursing Delirium Screening Scale (NuDESC) Score
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.
Time frame: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
Plan to share: No
Start is estimated for Dec 2026; primary completion for May 2027, 5 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Kocaeli City Hospital