PENG Block With Two Diffirent Volume

Not Applicable

Completed

• Conditions: Postoperative Pain; Hip Fractures; Pain, Acute
• Interventions: Other: Ultrasound guided PENG block with 20 mL Local Anesthetic solution; Other: Ultrasound guided PENG block with 30 mL Local Anesthetic solution

• Registration Number: NCT05358587
• Lead Sponsor: Samsun University

Brief Summary

Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.

Detailed Description

Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.

60 ASA I-III patients between 35-90 years of age who will be operated for femoral head/neck fractures will be included in the study. US-guided block procedure will be applied 30 minutes before the start of surgery. The patients will be divided into two groups, Group I, PENG block 20ml bupivacaine (n:30) and Group II, PENG block 30ml bupivacaine (n:30) using the closed envelope method in the operating room. Randomization will be performed by one of the researchers for each patient. Randomization information of patients will be used for all follow-up and data collection. The anesthetist applying the block will not take any part in collecting the data or performing the analysis. Numerical rating scale (NRS) will be used to evaluate pain. Patients will be given spinal anesthesia 30 minutes after PENG block. The primary outcome measure was determined as pain during positioning. NRS scores will be recorded after entering the operating room before, immediately before, during, and immediately after any analgesic intervention. Secondary outcome measures will be determined as the time required for LA performance (measured from the start of the position maneuvers to removal of the spinal needle), the quality of the patient position for LA performance ("unsatisfactory", "satisfactory", "good", "very good" to define SA). Questionnary 15 test will be applied to the patients 24 hours after the operation to measure patient satisfaction and to measure patient satisfaction.

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-03
• Study Start: 2022-05-09
• Primary Completion: 2023-12-29
• Status Verified: 2024-01
• Study Completion: 2024-01-04
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients scheduled for total hip replacement surgery under spinal anesthesia
• ASA(American Society of Anesthesiology) 1-3
• Receiving consent that accept regional analgesia

Exclusion Criteria

• contraindications for spinal anesthesia and PENG block
• impaired cognition or dementia
• multiple fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENG (20 mL)	Ultrasound guided PENG block with 20 mL Local Anesthetic solution	In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %)
PENG (30 mL)	Ultrasound guided PENG block with 30 mL Local Anesthetic solution	In this group, US guided PENG block will be performed with 30 ml of Bupivacaine solution (0.25 %)

Primary Outcome Measures

Name	Time	Method
Pain scores on the Numeric Rating Scale (NRS)	30 minutes after intervention (PENG block) ]	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").

Secondary Outcome Measures

Name	Time	Method
Quality of recovery 15 scale	24 hours after surgery	Postoperative Quality of Recovery 15 in Turkish scale
Quality of patient's position	up to ten minutes	The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
Quadriceps weakness	postoperative 6th and 24th hours	Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
analgesic consumption	24 hours	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.
Duration of spinal anesthesia performance	up to ten minutes	It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal

Trial Locations

Locations (1)

Samsun University; 🇹🇷 Samsun, Turkey