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Clinical Trials/NCT05358587
NCT05358587
Completed
Not Applicable

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

Samsun University1 site in 1 country60 target enrollmentMay 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
Samsun University
Enrollment
60
Locations
1
Primary Endpoint
Pain scores on the Numeric Rating Scale (NRS)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2022
End Date
January 4, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Samsun University
Responsible Party
Principal Investigator
Principal Investigator

Gamze Ertas

anesthesiologist

Samsun University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain scores on the Numeric Rating Scale (NRS)

Time Frame: 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 Outcomes

  • Quality of recovery 15 scale(24 hours after surgery)
  • Quality of patient's position(up to ten minutes)
  • Quadriceps weakness(postoperative 6th and 24th hours)
  • analgesic consumption(24 hours)
  • Duration of spinal anesthesia performance(up to ten minutes)

Study Sites (1)

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