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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06226675
Other study ID # 2020/15-14
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date April 1, 2024

Study information

Verified date January 2024
Source Zonguldak Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date April 1, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Procedure:
PENG Block
To apply local anesthetic under psoas tendon
LFCN block
to apply local anesthetic around lateral femoral cutaneous nerve

Locations

Country Name City State
Turkey Zonguldak Bülent Ecevit University Zonguldak Kozlu

Sponsors (1)

Lead Sponsor Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative opioid consumption total morphine requirement up to 24 hour after surgery
Secondary pain scores evaluating pain scores by Numeric Rating Score up to 24 hour after surgery
Secondary first analgesic time the need of first analgesic after surgery up to 24 hour after surgery
Secondary postoperative complications nausea-vomitting, motor block, hypertension, hypotension etc. up to 24 hour after surgery
Secondary mobilization time when the patient is first mobilized up to 24 hour after surgery
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