Pericapsular Nerve Block and Iliopsoas Fascial Plane Block in Hip Surgery

Hip Fractures Clinical Trial

Official title:

Comparison of Pericapsular Nerve Block and Iliopsoas Fascial Plane Block Effects on Postoperative Pain and Motor Weakness in Hip Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267716
• Other study ID #: 274-2023
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: Haseki Training and Research Hospital
• Contact: Berna Caliskan, MD
• Phone: +905067108770
• Email: caliskan.b[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective randomized interventional study aims to compare the effects of two peripheral nerve blocks, the periencapsular nerve block (PENG) and iliopsoas block (IPB), on analgesia and motor function after hip surgery. The main questions it aims to answer are the effectivity of postoperative pain management the preservation of motor movement. Participants will receive standardized general anesthesia and postoperative PENG or IPB in either Group. Researchers will compare the total amount of rescue analgesia and numeric rating scale with accompanying evaluating motor function at the same time intervals within 24 hour.

Description:

Providing postoperative analgesia after hip joint surgery is essential in ensuring patient recovery and rehabilitation. The blocks that can be used as alternatives in these surgeries have diversified in recent years, and their superiority over each other is being investigated. The aim is to reach a method that provides more effective analgesia, is more practical and does not cause muscle weakness. For this reason, PENG, which has no previous comparative randomized studies, and iliopsoas blocks, which have more recent clinical studies, need to be examined. All patients received standard general anaesthesia under standard monitoring along with the bispectral index (Medtronic) and nociception level index (NOL, MedaSense). Intubation was performed by administering intravenous (IV) 0,03 mg/kg midazolam 2 mg/kg, propofol (Lipuro, Braun), 2 mcg/kg fentanyl (Talinat, VEM), 0,6 mg /kg rocuronium (Esmeron, Alessandroorsini) followed by 1 MAC sevoflurane (Sevorane, Abbott) in an air-oxygen mixture for maintenance of anaesthesia. All participants received 20 mg tenoxicam and 1 gr paracetamol along with 8 mg dexamethasone before surgical incision as part of multimodal analgesia. All blocks were performed before surgical incision following the induction of general anaesthesia by a single experienced regional anaesthesiologist (B.C.) under ultrasound guidance (Esaote MyLab ™ Seven). Both groups received lateral femoral cutaneous nerve (LFCN) block by using a high-frequency probe to visualize LFCN between sartorius and tensor of fascia lata in line with the inguinal ligament, and 10 ml 0,375 bupivacaine was injected. After applying PENG or IP block in accordance with randomization, the surgery was set to begin after at least 15 minutes of block procedures. The intraoperative analgesic need was supplied by remifentanil infusion (2 mcg/mL) and determined by NOL index level, and a value over 25 for more than one minute was accepted as pain to be treated by increased remifentanil infusion doses. All patients received 8 mg of ondansetron and suggamadex (2 mg/kg) for decurarization before arousal under BIS guidance. From the beginning of acclaimed arousal till the 24th hour, rescue analgesia as tramadol 100 mg (maximum daily dose 400 mg) is applied if NOL is over 25 at the recovery room or NRS over 4 or with the patient's request. The routine analgesia regimen was 1 gram iv paracetamol 6th hourly postoperatively at the orthopaedic ward. PENG block procedure Immediately after the insurance of general anaesthesia and LFCN block application, PENG block was performed by the primary investigator (B.C) following proper skin disinfection with the patient in the supine position. Under the guidance of a low-frequency curvilinear ultrasound probe, the iliopubic eminence and the psoas tendon were identified, and local anaesthetic (20 ml 0,375% bupivacaine) was injected between the periosteum and psoas tendon following negative aspiration. IPB procedure After ensuring aseptic conditions, the low-frequency curvilinear ultrasound probe was transversely placed caudad to the anterior superior iliac spine, then rotated anticlockwise and slid along the inguinal ligament to detect the head of the femur, as described by Nielsen et al. The primary investigator (B.C.) directed the needle tip into the iliopsoas plane between the iliopsoas muscle and iliofemoral ligament through an in-plane approach, and 10 ml of 0,375% bupivacaine was injected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients eligible for inclusion in this study were those aged 18 to 90 years who had undergone total hip arthroplasty surgery and had an American Society of Anesthesiologists (ASA) Physical Status classification of I to III and body mass index (BMI) between 18 and 30 kg/m2.

Exclusion Criteria:

• Patients were excluded if they had one of the following criteria: refusal to participate, a history of neurological deficits or neuropathy affecting the lower extremity, infection at the site of block application, coagulopathy; allergy to local anaesthetics, epilepsy or treatment with antipsychotics; abuse of alcohol or drugs; previous surgery distorting the anatomy of the inguinal or supra inguinal areas; severe organ dysfunction ( kidney, liver and other); uncooperative patients who fail to respond reliably to verbal pain assessment.

Related Conditions & MeSH terms

• Hip Fractures
• Peripheral Nerve Block

Intervention

Procedure:
• PENG block
preoperative ultrasound-guided pericapsular nerve group block
• IPB
preoperative ultrasound-guided iliopsoas plane block

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul	Sultangazi

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Jessen C, Brix LD, Nielsen TD, Espelund US, Lund B, Bendtsen TF. Efficacy of iliopsoas plane block for patients undergoing hip arthroscopy: a prospective, triple-blind, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2023 Nov 30:rapm-2023-104989. doi: 10.1136/rapm-2023-104989. Online ahead of print. — View Citation

Yeoh SR, Chou Y, Chan SM, Hou JD, Lin JA. Pericapsular Nerve Group Block and Iliopsoas Plane Block: A Scoping Review of Quadriceps Weakness after Two Proclaimed Motor-Sparing Hip Blocks. Healthcare (Basel). 2022 Aug 18;10(8):1565. doi: 10.3390/healthcare10081565. Erratum In: Healthcare (Basel). 2022 Sep 19;10(9): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative motor block	postoperative motor block was assessed using knee extension and hip adduction observed by the blinded orthopedic surgeon	postoperative 24 hour
Secondary	pain scores	numeric rating scales as (NRS) which ranges from 0 to 10, where zero represents the absence of pain, and 10 signifies the worst imaginable pain. NRS scores were evaluated at several time points	postoperative 24 hour
Secondary	total analgesia, intraoperative	intraoperative remifentanil needed guided by nociception level index monitorization	intraoperatively
Secondary	total rescue analgesia	rescue analgesia will be given as tramadol 100 mg if pain scores over 4 or existance of patient request	postoperative 24 hour