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Completed

NCT Number: NCT05358587

PENG Block With Two Diffirent Volume

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.

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Key information

Conditions

Pain, Acute Acute Pain Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Wounds and Injuries

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun University

Samsun, 55040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided PENG block with 20 mL Local Anesthetic solution

Other

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.

Ultrasound guided PENG block with 30 mL Local Anesthetic solution

Other

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.

Primary outcomes

  1. 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

  1. Duration of spinal anesthesia performance

    Time frame: up to ten minutes

    It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal

  2. Quality of patient's position

    Time frame: up to ten minutes

    The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"

  3. analgesic consumption

    Time frame: 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.

  4. Quality of recovery 15 scale

    Time frame: 24 hours after surgery

    Postoperative Quality of Recovery 15 in Turkish scale

  5. Quadriceps weakness

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 3, 2022
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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