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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183541
• Other study ID #: UERH-AR-ZT-03
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Umraniye Education and Research Hospital
• Contact: Zeliha Tuncel, MD
• Phone: +905053577483
• Email: zelihalara[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 31, 2024
• Est. primary completion date: June 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Turkey	Umraniye Education and Research Hospital	Istanbul	Umraniye
Turkey	UmraniyeERH	Istanbul	Umraniye

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain score	VAS pain score	30 min, 12th, 24th and 48th hours in the postoperative period
Primary	Total opioid consumption	Tramadol (mg)	postoperative 48 hours
Primary	mobilisation time	take 5 steps with walker	postoperative 24-48 hours
Secondary	PENG block adverse events	motor block, nerve damage, hypotension, bradycardia	between the time surgery starts and the 48th hour
Secondary	length of hospital stay	day	between the time of hospitalization for the operation and discharge (day)