PENG vs Intra-articular Injection for Hip Arthroscopy

NCT04698746 | Unknown

• 1 other identifier: 71306642-050.05.04-
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

Hip arthroscopy, intra-articular injection, PENG block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain intensity score

  0.5, 1, 3, 6, 12, 24 hours postoperatively.

• First rescue analgesic time

  up to the first 24 hours postoperatively

• Postoperative nausea and vomiting

  up to the first 24 hours postoperatively

• Patient satisfaction

  at the end of 24 hours postoperatively

Study Arms (2)

Ultrasound guided pericapsular nerve group block

ACTIVE COMPARATOR

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

Procedure: Pericapsular nerve group block

Intra-articular local anesthetic injection

ACTIVE COMPARATOR

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.

Procedure: Intra-articular local anesthetic injection

Interventions

Pericapsular nerve group block PROCEDURE

PENG block will be made with 15 ml 0.5% bupivacaine + 2 mg dexamethasone + 14.5 ml NaCl under US-guidance

Ultrasound guided pericapsular nerve group block

Intra-articular local anesthetic injection PROCEDURE

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

Intra-articular local anesthetic injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Pain

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Yeşiltaş

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serdar Yeşiltaş, Asist Prof.

CONTACT

05423632630; syesiltas@bezmialem.edu.tr

Yeşiltaş, Asist Prof.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: January 20, 2021
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

TU (1)