PENG vs Intra-articular Injection for Hip Arthroscopy

NCT ID: NCT04698746

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2024-04-30

Brief 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.

Conditions

Opioid Use; Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ultrasound guided pericapsular nerve group block

Injection of 15 ml 0.5% bupivacaine + 2 mg dexamethasone + 14.5 ml isotonic saline mixture between iliopubic eminentia and psoas tendon under ultrasound guidance

Group Type: ACTIVE_COMPARATOR

Pericapsular nerve group block

Intervention Type: PROCEDURE

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

At the end of the surgical case, a total of 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml isotonic saline injection intra-articularly.

Group Type: ACTIVE_COMPARATOR

Intra-articular local anesthetic injection

Intervention Type: PROCEDURE

Intra-articular local anesthetic injection will be made with 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml NaCl

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Serdar Yeşiltaş

Assist Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yeşiltaş

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakıf University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Serdar Yeşiltaş, Asist Prof.

Role: CONTACT

syesiltas@bezmialem.edu.tr

05423632630

Yeşiltaş, Asist Prof.

Role: CONTACT

Facility Contacts

Serdar Yeşiltaş, Assist.Prof

Role: primary

syesiltas@bezmialem.edu.tr

05423632630

Other Identifiers

71306642-050.05.04-

Identifier Type: -

Identifier Source: org_study_id