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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04871061
Other study ID # PENG55
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 6, 2021
Est. completion date July 5, 2021

Study information

Verified date April 2022
Source Cigli Regional Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate of analgesic effects of pericapsullar nerve group block which is performed preoperatively to assist positioning patients for performance of spinal anesthesia.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 5, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 35 Years to 90 Years
Eligibility Inclusion Criteria: - hip fracture - aged between 35 and 90 years old Exclusion Criteria: - contraindications for spinal anesthesia and PENG block - impaired cognition or dementia - multiple fractures - any previous analgesic administration during the last 12 hours

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
PENG Block
Pericapsular Nerve Group Block
Drug:
Conventional opioid analgesia (Fentanyl)
standardised intravenous opioid

Locations

Country Name City State
Turkey Hakan Aygün Izmir

Sponsors (1)

Lead Sponsor Collaborator
Cigli Regional Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain scores on the Numeric Rating Scale (NRS) Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Secondary Duration of spinal anesthesia performance It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Secondary Quality of patient's position The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good" Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Secondary Analgesic consumption In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups. 24 hours
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