PENG Block With Two Diffirent Volume

Comparison of the Perioperative Analgesic Efficacy of PENG Block Applications With Two Different Volumes in Patients Undergoing Hip Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Hip Fractures; Pain, Acute
• Intervention / Treatment: Other: Ultrasound guided PENG block with 20 mL Local Anesthetic solution; Other: Ultrasound guided PENG block with 30 mL Local Anesthetic solution

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gamze Ertas, specialist; Phone Number: 905056587914; Email: gamzertas.md@hotmail.com

Study Locations

• Turkey
  • Samsun, Turkey, 55040
    • Samsun University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENG (20 mL); In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %)	Other: 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 %). Block will be performed 30 minutes before spinal anesthesia.
Experimental: PENG (30 mL); In this group, US guided PENG block will be performed with 30 ml of Bupivacaine solution (0.25 %)	Other: Ultrasound guided PENG block with 30 mL Local Anesthetic solution; In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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").	30 minutes after intervention (PENG block) ]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of spinal anesthesia performance	It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal	up to ten minutes
Quality of patient's position	The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"	up to ten minutes
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
Quality of recovery 15 scale	Postoperative Quality of Recovery 15 in Turkish scale	24 hours after surgery
Quadriceps weakness	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).	postoperative 6th and 24th hours

Collaborators and Investigators

• Sponsor: Samsun University
• Investigators: Principal Investigator: Gamze Ertas, specialist, samsun university, samsun training and research hospital

Publications and helpful links

General Publications

• Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6. Erratum In: Reg Anesth Pain Med. 2022 Jul;47(7):e4.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Pharmaceutical Solutions; Anesthetics, Local
• Other Study ID Numbers: PENG_55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No