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PENG vs Intra-articular Injection for Hip Arthroscopy (PARİAH)

Primary Purpose

Opioid Use, Acute Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pericapsular nerve group block
Intra-articular local anesthetic injection
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring Hip arthroscopy, intra-articular injection, PENG block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakıf UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound guided pericapsular nerve group block

Intra-articular local anesthetic injection

Arm Description

Injection of 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml isotonic saline mixture between iliopubic eminentia and psoas tendon under ultrasound guidance

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.

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
Total amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.

Secondary Outcome Measures

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.
First rescue analgesic time
The investigators will collect time to first rescue analgesic consumption in each group
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).
Patient satisfaction
Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)

Full Information

First Posted
January 5, 2021
Last Updated
September 28, 2022
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04698746
Brief Title
PENG vs Intra-articular Injection for Hip Arthroscopy
Acronym
PARİAH
Official Title
Pericapsular Nerve Group (PENG) Block Versus Intra-articular Injection for Hip Arthroscopy: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Acute Pain
Keywords
Hip arthroscopy, intra-articular injection, PENG block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided pericapsular nerve group block
Arm Type
Active Comparator
Arm Description
Injection of 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml isotonic saline mixture between iliopubic eminentia and psoas tendon under ultrasound guidance
Arm Title
Intra-articular local anesthetic injection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block
Intervention Description
PENG block will be made with 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml NaCl under US-guidance
Intervention Type
Procedure
Intervention Name(s)
Intra-articular local anesthetic injection
Intervention Description
Intra-articular local anesthetic injection will be made with 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml NaCl
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Total amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Time Frame
up to the first 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain intensity score
Description
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.
Time Frame
0.5, 1, 3, 6, 12, 24 hours postoperatively.
Title
First rescue analgesic time
Description
The investigators will collect time to first rescue analgesic consumption in each group
Time Frame
up to the first 24 hours postoperatively
Title
Postoperative nausea and vomiting
Description
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).
Time Frame
up to the first 24 hours postoperatively
Title
Patient satisfaction
Description
Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Time Frame
at the end of 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serdar Yeşiltaş, Asist Prof.
Phone
05423632630
Email
syesiltas@bezmialem.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Yeşiltaş, Asist Prof.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeşiltaş
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serdar Yeşiltaş, Assist.Prof
Phone
05423632630
Email
syesiltas@bezmialem.edu.tr

12. IPD Sharing Statement

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PENG vs Intra-articular Injection for Hip Arthroscopy

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