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

April 13, 2022 updated by: Hakan Aygün, Cigli Regional Training Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35575
        • Hakan Aygün

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PENG Block
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.
Procedure: PENG Block
Pericapsular Nerve Group Block
Active Comparator: Control
in this group, standardised opioid doses (drug: Fentanyl) will be used for analgesia for positioning pain
Drug: Conventional opioid analgesia (Fentanyl)
standardised intravenous opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores on the Numeric Rating Scale (NRS)
Time Frame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
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").
Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of spinal anesthesia performance
Time Frame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Quality of patient's position
Time Frame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Analgesic consumption
Time Frame: 24 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cigli Regional Training Hospital

Investigators

  • Study Director: Hakan Aygun, MD, Cigli RTH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 5, 2021

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PENG55

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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