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Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients

Primary Purpose

Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PENG Block
Conventional opioid analgesia (Fentanyl)
Sponsored by
Cigli Regional Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring hip fracture, postoperative analgesia, positioning pain

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hip fracture
  • aged between 35 and 90 years old

Exclusion Criteria:

  • contraindications for spinal anesthesia and PENG block
  • impaired cognition or dementia
  • multiple fractures
  • any previous analgesic administration during the last 12 hours

Sites / Locations

  • Hakan Aygün

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PENG Block

Control

Arm Description

For patients with hip fracture and having hip surgery this study evaluates the analgesic effects of Pericapsular Nerve Group (PENG) block for positioning before spinal anesthesia.

in this group, standardised opioid doses (drug: Fentanyl) will be used for analgesia for positioning pain

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.

Full Information

First Posted
April 25, 2021
Last Updated
April 13, 2022
Sponsor
Cigli Regional Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04871061
Brief Title
Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients
Official Title
Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cigli Regional Training Hospital

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
The purpose of this study is to evaluate of analgesic effects of pericapsullar nerve group block which is performed preoperatively to assist positioning patients for performance of spinal anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
hip fracture, postoperative analgesia, positioning pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated randomization codes.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PENG Block
Arm Type
Active Comparator
Arm Description
For patients with hip fracture and having hip surgery this study evaluates the analgesic effects of Pericapsular Nerve Group (PENG) block for positioning before spinal anesthesia.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
in this group, standardised opioid doses (drug: Fentanyl) will be used for analgesia for positioning pain
Intervention Type
Procedure
Intervention Name(s)
PENG Block
Intervention Description
Pericapsular Nerve Group Block
Intervention Type
Drug
Intervention Name(s)
Conventional opioid analgesia (Fentanyl)
Intervention Description
standardised intravenous opioid
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
Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 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
Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Title
Quality of patient's position
Description
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
Time Frame
Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
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

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: hip fracture aged between 35 and 90 years old Exclusion Criteria: contraindications for spinal anesthesia and PENG block impaired cognition or dementia multiple fractures any previous analgesic administration during the last 12 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakan Aygun, MD
Organizational Affiliation
Cigli RTH
Official's Role
Study Director
Facility Information:
Facility Name
Hakan Aygün
City
İzmir
ZIP/Postal Code
35575
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25068412
Citation
Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.
Results Reference
result

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Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients

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