Pericapsular Nerve Block Versus Propofol During Hip Fractures Surgery

October 7, 2024 updated by: Marwa Emam, Ain Shams University

Pericapsular Nerve Group (PENG) Block Versus Low Dose Propofol to Achieve Painless Sitting Position Before Spinal Anesthesia in Patients With Hip Fractures

The study will compare the efficacy of Pericapsular nerve group block (PENG) versus low dose Propofol for the achievement of painless sitting position before spinal anesthesia in patients undergoing repair of Hip fractures.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients in the age group ranging 40-70, both genders, belonging to physical status American Society of Anaesthesiologists (ASA) I and II

Exclusion Criteria:

  • Patients with old fractures (more than 7 days), polytrauma, bleeding disorders or coagulopathy, local site infection, difficulty expressing pain scores such as hearing disability, mentally challenged, dementia or psychiatric illness and who refused to take part

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Group (A ) : will receive ultrasound guided pericapsular nerve group block (PENG) followed by spinal anesthesia.
Procedure: pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B
Patients in group A will receive ultrasound guided pericapsular nerve group block (PENG) while patients in group B will receive low dose intravenous Propofol0.7mg/kg] over 30 seconds followed by spinal anesthesia in both groups
Active Comparator: Group B
Group B will receive low dose intravenous Propofol [0.7mg/kg] over 30 seconds followed by spinal anesthesia and so far, this is the most common and standard technique to achieve sitting position during spinal anesthesia for patients with hip fractures.
Procedure: pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B
Patients in group A will receive ultrasound guided pericapsular nerve group block (PENG) while patients in group B will receive low dose intravenous Propofol0.7mg/kg] over 30 seconds followed by spinal anesthesia in both groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in VAS scale
Time Frame: 30 min after giving propofol and the PENG block.
The primary outcome will be difference in median reduction in VAS-D .
30 min after giving propofol and the PENG block.

Collaborators and Investigators

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

Sponsor

Ain Shams University

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 (Estimated)

October 21, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

February 15, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 130/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol

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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