'The Effect of Adding LFCN Block to PENG

NCT06226675 | Unknown

• 1 other identifier: 2020/15-14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Pain, Acute; Nerve Block; Opioid Consumption

Keywords

lateral femoral cutaneous nerve block; PENG block; Pain management; Opioid consumption

Outcome Measures

Primary Outcomes (1)

• postoperative opioid consumption

  total morphine requirement

  up to 24 hour after surgery

Secondary Outcomes (4)

• pain scores

  up to 24 hour after surgery

• first analgesic time

  up to 24 hour after surgery

• postoperative complications

  up to 24 hour after surgery

• mobilization time

  up to 24 hour after surgery

Study Arms (3)

Group Control

NO INTERVENTION

Group PENG

ACTIVE COMPARATOR

Procedure: PENG Block

Group PENG+LFCN

ACTIVE COMPARATOR

Procedure: PENG Block; Procedure: LFCN block

Interventions

PENG Block PROCEDURE

To apply local anesthetic under psoas tendon

Group PENG; Group PENG+LFCN

LFCN block PROCEDURE

to apply local anesthetic around lateral femoral cutaneous nerve

Group PENG+LFCN

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 26, 2024
• Study Start: January 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: April 1, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)