Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients

Pain, Acute Clinical Trial

Official title:

Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871061
• Other study ID #: PENG55
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Pain
• Hip Fractures
• Pain, Acute

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