PENG vs Intra-articular Injection for Hip Arthroscopy

Opioid Use Clinical Trial

— PARIAH  

Official title:

Pericapsular Nerve Group (PENG) Block Versus Intra-articular Injection for Hip Arthroscopy: A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04698746
• Other study ID #: 71306642-050.05.04-
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Bezmialem Vakif University
• Contact: Serdar Yesiltas, Asist Prof.
• Phone: 05423632630
• Email: syesiltas[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hip arthroscopy is a popular surgical method that is increasingly being used for both intraarticular and extraarticular hip surgeries. Postoperative acute pain is difficult to control in hip surgeries due to the complex nature of hip innervation and the large number of surgical interventions. Optimal treatment of postoperative pain in hip arthroscopy is very important to be able to perform rehabilitation, avoid opioid side effects and minimize unplanned re-hospitalization. Regional anesthesia techniques are widely used because of their proven efficacy in post-surgical pain management and their safety profile that ultimately contributes to early recovery. Many regional techniques such as neuraxial blocks, lumbar plexus block, femoral nerve block, fascia iliac block and intraarticular local anesthetic injection have been used for the treatment of acute postoperative pain.

Femoral nerve and fascia iliac blocks have shown good results for long-term post-surgery analgesia. However, the obturator nerve and accessory obturator nerve should be targeted to achieve more effective perioperative pain control. There are studies reporting that pericapsular nerve group block (PENG), which has been defined in recent years, provides effective perioperative analgesia in hip surgeries. In this study, we aim to compare the effectiveness of PENG block and intra-articular local anesthetic injection in hip arthroscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• American Association of Anesthesiologists (ASA) physical status I - III

• BMI 20 to 35 kg / m2

• Patients scheduled for elective hip arthroscopy

• Able to provide informed consent.

Exclusion Criteria:

• Patients who refuse to participate in the study,

• Coagulopathy,

• Sepsis,

• Hepatic or renal insufficiency,

• Pregnancy

• Allergy to local anesthetic drugs,

• Chronic pain condition requiring opioid intake at home,

• BMI above 40.

• History of psychiatric diseases needing treatment.

• Failure of nerve block

• Substance abuse history

• Hip revision surgery

• Underlying neurologic disorder affecting pain perception.

• Angina, heart attack, heart failure

• Kidney or hepatic insufficiency

• Stroke

• Gastrintestinal bleeding history

Related Conditions & MeSH terms

• Acute Pain
• Opioid Use

Intervention

Procedure:
• Pericapsular nerve group block
PENG block will be made with 15 ml 0.5% bupivacaine + 2 mg dexamethasone + 14.5 ml NaCl under US-guidance
• Intra-articular local anesthetic injection
Intra-articular local anesthetic injection will be made with 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml NaCl

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	Total amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.	up to the first 24 hours postoperatively
Secondary	Pain intensity score	Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be ) at 0.5, 1, 3, 6, 12, 24 hours postoperatively.	0.5, 1, 3, 6, 12, 24 hours postoperatively.
Secondary	First rescue analgesic time	The investigators will collect time to first rescue analgesic consumption in each group	up to the first 24 hours postoperatively
Secondary	Postoperative nausea and vomiting	Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).	up to the first 24 hours postoperatively
Secondary	Patient satisfaction	Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)	at the end of 24 hours postoperatively