Effects of Pericapsular Nerve Group Block on Postoperative Recovery for Total Hip Arthroplasty

Analgesia Clinical Trial

Official title:

Effects of Pericapsular Nerve Group Block on Postoperative Recovery for Total Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183528
• Other study ID #: UERH-AR-ZT-02
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 8, 2024

Study information

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

Clinical Trial Summary

The hypothesis of this study is that patients who undergo PENG block in before Total Hip Artroplasthy (THA) surgery with spinal anesthesia will have reduced postoperative pain scores, less need for opioid analgesics and earlier mobilisation.

Description:

This prospective randomised controlled study included a total of 60 patients aged 40-85 years who underwent THA surgery under spinal anaesthesia. Patients were divided into two groups as PENG block (n:30) and non-PENG block (n:30). PENG block was placed in the fascial plane between the pseudotendon and pubic ramus with USG in-plane technique, 20 ml of 0.5% bupivacaine was administered and surgery was initiated. The primary outcome of the study was to investigate the effect of preoperative PENG block application on postoperative pain, opioid requirement, mobilisation time, hip joint patency and length of hospital stay in patients undergoing THA surgery. The secondary outcome was to investigate the effect of PENG block on perioperative haemodynamics and postoperative side effects.

For multimodal analgesia, 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical wound incision line by the surgical team at the end of surgery. After tramadol 50 mg loading with PCA device, a basal rate of 5-10 mg/hour (20 mg bolus dose + 30 minutes lock time) is given with paracetamol 10 mg/kg iv (8 hours interval).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 8, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• THA performed by posterior approach

• 40-85 age range

• ASA 1-3

Exclusion Criteria:

Under 40 years of age, over 85 years of age,

• ASA 4 and above,

• Cognitive impairment (Alzheimer's disease, dementia, delirium etc.),

• Hip fracture,

• Application site infection,

• Allergy to local anaesthetic agents,

• Patients are non-consenting patients.

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative

Intervention

Procedure:
• Pericapsular Nerve Group (PENG) Block
With ultrasonography-guided PENG block, the femoral, obturator and accessory obturator nerve branches that provide sensory innervation of the anterior surface of the hip joint capsule are blocked .

Locations

Country	Name	City	State
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	recovery room 30 min, 12., 24. and 48. hours in the postoperative period
Primary	mobilisation time	walking 5 steps with walker	24 -48 hours
Primary	hip joint patency	Measurement of joint movement angle with goniometer (angle)	24. hours
Primary	total opioid consumption	Tramadol total usage (mg)	48 hours
Secondary	PENG block side effects	motor block, nausea, vomiting, anaphylaxis, nerve damage	The first 48 hours after performing the PENG block
Secondary	Perioperative haemodynamic data	heart rate, mean arterial pressure	T1: 30 minutes (min) after spinal anesthesia, T2: at the end of the surgical procedure, T3: at 30 minutes after recovery
Secondary	length of hospital stay	hospitalization and discharge time for surgery	day