Postoperative Analgesic Efficacy of Pericapsular Nerve Group Block (PENG) Block for Knee Arthroscopy
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PENG Block combinated with PCA
PCA
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Patients agreed to receive PENG block
- Knee arthroscopy
Exclusion Criteria:
- Other kinds of knee surgery
- Patients refuse to receive PENG block
Sites / Locations
- KSU Faculty of Medicine Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
PENG Block
CONTROL
Arm Description
PENG Block combinate with PCA
PCA
Outcomes
Primary Outcome Measures
First analgesic demand
The time interval from PENG blocks to the first analgesic demand.
Secondary Outcome Measures
Opioid consumption
Total opioid analgesic consumption
Numeric Rating Scale
The maximum score on a 10cm numeric rating scale: (0 to 10cm) (0 = no pain, 10 = worst imaginable pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04738500
Brief Title
Postoperative Analgesic Efficacy of Pericapsular Nerve Group Block (PENG) Block for Knee Arthroscopy
Official Title
Postoperative Analgesic Efficacy of Pericapsular Nerve Group Block (PENG) Block for Knee Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2021 (Anticipated)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bora Bilal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pericapsular nerve group block (PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee arthroscopy.
Detailed Description
Pericapsular nerve group block(PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee artroscopy. Blockade of the branches of the femoral and obturator nerves that provide innervation to any structures distal enough to be useful in knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PENG Block
Arm Type
Active Comparator
Arm Description
PENG Block combinate with PCA
Arm Title
CONTROL
Arm Type
Sham Comparator
Arm Description
PCA
Intervention Type
Procedure
Intervention Name(s)
PENG Block combinated with PCA
Other Intervention Name(s)
PCA
Intervention Description
After spinal anesthesia PENG block will be performed
Intervention Type
Procedure
Intervention Name(s)
PCA
Intervention Description
PCA will be applied after surgery
Primary Outcome Measure Information:
Title
First analgesic demand
Description
The time interval from PENG blocks to the first analgesic demand.
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
Total opioid analgesic consumption
Time Frame
24 Hours
Title
Numeric Rating Scale
Description
The maximum score on a 10cm numeric rating scale: (0 to 10cm) (0 = no pain, 10 = worst imaginable pain)
Time Frame
24 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients agreed to receive PENG block
Knee arthroscopy
Exclusion Criteria:
Other kinds of knee surgery
Patients refuse to receive PENG block
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bora Bilal, Assos. Prof.
Phone
05052354430
Email
bilalbora@yahoo.com
Facility Information:
Facility Name
KSU Faculty of Medicine Research Hospital
City
Kahramanmaraş
ZIP/Postal Code
46200
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bora Bilal
Phone
03443003245
Email
bbilal@ksu.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postoperative Analgesic Efficacy of Pericapsular Nerve Group Block (PENG) Block for Knee Arthroscopy
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