'The Effect of Adding LFCN Block to PENG

January 17, 2024 updated by: Keziban Bollucuoglu, Zonguldak Bulent Ecevit University

The Effect of Adding Lateral Femoral Cutaneous Nerve Block to PENG Block on Postoperative Opioid Consumption in Hip Surgery

The incidence of femoral neck fracture in Europe is 330/10000 per year. It is increasing every year due to the aging of the population. In patients 55 years and older, hip fracture-related mortality is estimated to be between 4% and 16% at one month and between 11% and 43% at one year after surgery. The reduced risk of postoperative complications associated with the use of regional anesthesia, shorter mobilization times, and reduced morphine consumption in hip fractures have been reported, and have been incorporated into postoperative pain control as part of multimodal strategies. PENG has been described for postoperative pain control for surgery on the hip joint or for the treatment of post-traumatic pain associated with proximal femur/femoral head fractures. Lateral femoral cutaneous nerve block is used in combination with other peripheral block methods to provide analgesia in the lateral thigh.

The investigators aimed to evaluate the effect of adding lateral femoral cutaneous nerve block to PENG block on pain scores and opioid consumption in femoral fracture procedures under spinal anesthesia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Turkey
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bulent Ecevit University

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

Yes

Description

Inclusion Criteria:

  • 18-75 years old,
  • ASA I-II-III risk group
  • patients undergoing hip fracture surgery under spinal anesthesia
  • Patients whose informed consent was read and consent was obtained from them and their representatives.

Exclusion Criteria:

  • Those who do not want to participate in the study,
  • ASA IV-V patients
  • Those with coagulation disorders
  • Allergic to local anesthetics

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group Control
Active Comparator: Group PENG
Procedure: PENG Block
To apply local anesthetic under psoas tendon
Active Comparator: Group PENG+LFCN
Procedure: PENG Block
To apply local anesthetic under psoas tendon
Procedure: LFCN block
to apply local anesthetic around lateral femoral cutaneous nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative opioid consumption
Time Frame: up to 24 hour after surgery
total morphine requirement
up to 24 hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores
Time Frame: up to 24 hour after surgery
evaluating pain scores by Numeric Rating Score
up to 24 hour after surgery
first analgesic time
Time Frame: up to 24 hour after surgery
the need of first analgesic after surgery
up to 24 hour after surgery
postoperative complications
Time Frame: up to 24 hour after surgery
nausea-vomitting, motor block, hypertension, hypotension etc.
up to 24 hour after surgery
mobilization time
Time Frame: up to 24 hour after surgery
when the patient is first mobilized
up to 24 hour after surgery

Collaborators and Investigators

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

Sponsor

Zonguldak Bulent Ecevit 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 (Actual)

January 1, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Estimated)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/15-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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