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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06169462
Other study ID # 10-2023/17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 31, 2023
Est. completion date December 10, 2023

Study information

Verified date December 2023
Source Karaman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Ultrasound-guided Supra-inguinal Fascia Iliaca compartment Block (SIFCB) and Pericapsular Nerve Group Block (PENG) are increasingly being used for postoperative analgesia for hip surgery. The postoperative analgesic efficacy of SIFCB added to PENG block in elderly hip fracture patients will be evaluated. Postoperative opioid consumption and quality of recovery will also be evaluated.


Description:

The study was conducted as a retrospective cohort feasibility design within a tertiary hospital. Patient records and electronic data systems were used to gather the required data for analysis. Before surgery, a carefully selected cohort of patients who underwent PENG block and PENG block added SIFCB were included in the study.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 10, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria: - Physical status according to American Society of Anesthesiologists (ASA ) I-III Exclusion Criteria: - Previous operation on the same hip - Hepatic or renal insufficiency - Patients undergoing general anesthesia - Allergy or intolerance to one of the study medications - BMI >40 - ASA IV

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
PENG block
Patients underwent ultrasound-guided PENG Block for older adult patients surgery for hip fracture. Patients who received opioids as a rescue analgesic during postoperative pain management on selected dates will be included in the study.
PENG block+ SIFCB
Patients underwent ultrasound-guided PENG Block+ SIFCB for older adult patients surgery for hip fracture. Patients who received opioids as a rescue analgesic during postoperative pain management on selected dates will be included in the study.

Locations

Country Name City State
Turkey Karaman Training and Research Hospital Karaman Karaman/Merkez

Sponsors (1)

Lead Sponsor Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid consumption If the patient's Numerical Rating Scale (NRS) score is equal to or above 4, tramadol 50 mg IV or oxycodone 5 mg orally every 4 hours will be administered as rescue analgesia. Postoperative 48th hour
Secondary Numerical Rating Scale (NRS) scores Range 0-10, 0=no pain, 10=the worse pain ever Postoperative 48th hour
Secondary Quality of Recovery 15 Score Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better Postoperative day 1 and 1 month
Secondary Postoperative complications Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression 24 hours
Secondary Mobilization time Mobilization time 24 hours
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