Effects of Pericapsular Nerve Group Block Applied in Patients Undergoing Hip Fracture Surgery.

Effects of Pericapsular Nerve Group (PENG) Block Applied for Analgesia on the Postoperative Process in Patients Undergoing Hip Fracture Surgery.

In this study, it was aimed to compare the multimodal analgesia application or the pericapsular nerve group (PENG) block methods in patients undergoing hip surgery. The effectiveness and benefit rate of the PENG block in postoperative pain will be evaluated.

Postoperative pain, need for additional analgesia, range of motion of the hip joint, mobilization time, length of hospital time and adverse events in patients undergoing hip fracture surgery with and without PENG block will be investigated.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Hip Fractures
• Intervention / Treatment: Procedure: Pericapsular Nerve Group (PENG) Block

Detailed Description

This prospective randomised controlled study included a total of 70 patients aged 30-85 years who underwent hip fracture surgery under spinal anaesthesia. Patients were randomly divided into two groups using the sealed envelope method, Group I: those who received PENG block (n:35) and Group II:Those who did not receive PENG block (control group) (n: 35).

All patients will undergo hip fracture surgery by the same surgical team. Each patient will be informed about the procedure to be performed during anesthesia and surgery, and signed informed consent will be obtained before the procedure.Patients in Group I who will undergo the PENG block method; Before surgery, after spinal anesthesia, PENG block is performed under sterile conditions under ultrasonography guidance. With the patient supine, a 2-5 MHz, low-frequency, curvilinear probe is placed in the transverse plane medial to the anterior inferior iliac spine (AIIS), with the medial end of the probe rotated approximately 45° counterclockwise to align with the superior pubic ramus.

With the PENG block, an 80 mm block needle is placed in the fascial plane between the psoas tendon and the pubic ramus and 20 ml of 0.5% bupivacaine is administered.

As for the patients in Group II (control group); It is a routine practice at the end of surgery; 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical area by the surgical team.

For routine postoperative multimodal analgesia, intravenous PCA (patient controlled analgesia) was administered to patients in both groups with tramadol 50 mg at a basal rate of 10 mg / hour after loading (20 mg bolus dose + 30 minutes lock time) and paracetamol 10 mg / kg iv. (Given every 8 hours)

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zeliha Tuncel, MD; Phone Number: +905053577483; Email: zelihalara@yahoo.com
• Study Contact Backup: Name: Hale Arkan Tuna, MD; Phone Number: +905303705619; Email: halearkan@yahoo.com.tr

Study Locations

• Turkey
  • Umraniye
    • Istanbul, Umraniye, Turkey, 34734
      • Recruiting
      • UmraniyeERH
      • Contact: ZELİHA TUNCEL, ass prof; Phone Number: +905053577483; Email: zelihalara@yahoo.com
    • Istanbul, Umraniye, Turkey, 34734
      • Recruiting
      • Umraniye Education and Research Hospital
      • Contact: ZELİHA TUNCEL, ass prof; Phone Number: +905053577483; Email: zelihalara@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who will undergo hip fracture surgery Women and men aged 30-85

Exclusion Criteria:

• Patients under 30 years old, over 85 years old
• American Society of Anesthesiology (ASA) IV,
• Those with cognitive impairment (alzheimer, dementia, delirium, etc.)
• Those with application site infection
• Those who are allergic to local anesthetic substances
• Patients are non-consenting patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PENG Block group; PENG block group; USG probe is placed on the transverse plane medial to the anterior inferior iliac spine (AIIS), the medial end of the probe is placed on the superior pubic It is rotated approximately 45° counterclockwise to align it with the ramus. For the PENG block, an 80 mm block needle is placed in the fascial plane between the psoas tendon and pubic ramus and 20 ml of 0.5% bupivacaine is administered after spinal anesthesia,	Procedure: Pericapsular Nerve Group (PENG) Block; Pericapsular nerve group (PENG) block The femoral nerve and obturator nerve terminal branches, which provide sensory innervation of the hip joint, are blocked, thus providing analgesia without creating a motor block.
Other: Control group; Control group; 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical area by the surgical team at the end of surgery	Procedure: Pericapsular Nerve Group (PENG) Block; Pericapsular nerve group (PENG) block The femoral nerve and obturator nerve terminal branches, which provide sensory innervation of the hip joint, are blocked, thus providing analgesia without creating a motor block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain score	VAS pain score	30 min, 12th, 24th and 48th hours in the postoperative period
Total opioid consumption	Tramadol (mg)	postoperative 48 hours
mobilisation time	take 5 steps with walker	postoperative 24-48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PENG block adverse events	motor block, nerve damage, hypotension, bradycardia	between the time surgery starts and the 48th hour
length of hospital stay	day	between the time of hospitalization for the operation and discharge (day)

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital
• Investigators: Study Director: Zeliha Tuncel, MD, Umraniye Education and Research Hospita

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): May 8, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Anesthesia; PENG block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Pain, Postoperative; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: UERH-AR-ZT-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No