PENG Block With Two Diffirent Volume
Primary Purpose
Pain, Acute, Postoperative Pain, Hip Fractures
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound guided PENG block with 20 mL Local Anesthetic solution
Ultrasound guided PENG block with 30 mL Local Anesthetic solution
Sponsored by
About this trial
This is an interventional other trial for Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for total hip replacement surgery under spinal anesthesia
- ASA(American Society of Anesthesiology) 1-3
- Receiving consent that accept regional analgesia
Exclusion Criteria:
- contraindications for spinal anesthesia and PENG block
- impaired cognition or dementia
- multiple fractures
Sites / Locations
- Samsun UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PENG (20 mL)
PENG (30 mL)
Arm Description
In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %)
In this group, US guided PENG block will be performed with 30 ml of Bupivacaine solution (0.25 %)
Outcomes
Primary Outcome Measures
Pain scores on the Numeric Rating Scale (NRS)
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Secondary Outcome Measures
Duration of spinal anesthesia performance
It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
Quality of patient's position
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
analgesic consumption
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
Quality of recovery 15 scale
Postoperative Quality of Recovery 15 in Turkish scale
Quadriceps weakness
Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05358587
Brief Title
PENG Block With Two Diffirent Volume
Official Title
Comparison of the Perioperative Analgesic Efficacy of PENG Block Applications With Two Different Volumes in Patients Undergoing Hip Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsun University
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
Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.
Detailed Description
Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.
60 ASA I-III patients between 35-90 years of age who will be operated for femoral head/neck fractures will be included in the study. US-guided block procedure will be applied 30 minutes before the start of surgery. The patients will be divided into two groups, Group I, PENG block 20ml bupivacaine (n:30) and Group II, PENG block 30ml bupivacaine (n:30) using the closed envelope method in the operating room. Randomization will be performed by one of the researchers for each patient. Randomization information of patients will be used for all follow-up and data collection. The anesthetist applying the block will not take any part in collecting the data or performing the analysis. Numerical rating scale (NRS) will be used to evaluate pain. Patients will be given spinal anesthesia 30 minutes after PENG block. The primary outcome measure was determined as pain during positioning. NRS scores will be recorded after entering the operating room before, immediately before, during, and immediately after any analgesic intervention. Secondary outcome measures will be determined as the time required for LA performance (measured from the start of the position maneuvers to removal of the spinal needle), the quality of the patient position for LA performance ("unsatisfactory", "satisfactory", "good", "very good" to define SA). Questionnary 15 test will be applied to the patients 24 hours after the operation to measure patient satisfaction and to measure patient satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Postoperative Pain, Hip Fractures
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PENG (20 mL)
Arm Type
Experimental
Arm Description
In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %)
Arm Title
PENG (30 mL)
Arm Type
Experimental
Arm Description
In this group, US guided PENG block will be performed with 30 ml of Bupivacaine solution (0.25 %)
Intervention Type
Other
Intervention Name(s)
Ultrasound guided PENG block with 20 mL Local Anesthetic solution
Intervention Description
In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.
Intervention Type
Other
Intervention Name(s)
Ultrasound guided PENG block with 30 mL Local Anesthetic solution
Intervention Description
In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.
Primary Outcome Measure Information:
Title
Pain scores on the Numeric Rating Scale (NRS)
Description
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time Frame
30 minutes after intervention (PENG block) ]
Secondary Outcome Measure Information:
Title
Duration of spinal anesthesia performance
Description
It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
Time Frame
up to ten minutes
Title
Quality of patient's position
Description
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
Time Frame
up to ten minutes
Title
analgesic consumption
Description
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
Time Frame
24 hours
Title
Quality of recovery 15 scale
Description
Postoperative Quality of Recovery 15 in Turkish scale
Time Frame
24 hours after surgery
Title
Quadriceps weakness
Description
Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Time Frame
postoperative 6th and 24th hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for total hip replacement surgery under spinal anesthesia
ASA(American Society of Anesthesiology) 1-3
Receiving consent that accept regional analgesia
Exclusion Criteria:
contraindications for spinal anesthesia and PENG block
impaired cognition or dementia
multiple fractures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamze ertas, specialist
Phone
905056587914
Email
gamzertas.md@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze Ertas, specialist
Organizational Affiliation
samsun university, samsun training and research hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsun University
City
Samsun
ZIP/Postal Code
55040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze Ertas, specialist
Phone
905056587914
Email
gamzertas.md@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gamze Ertas, specialist
12. IPD Sharing Statement
Citations:
PubMed Identifier
34873023
Citation
Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6. Erratum In: Reg Anesth Pain Med. 2022 Jul;47(7):e4.
Results Reference
result
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PENG Block With Two Diffirent Volume
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