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Completed

NCT Number: NCT04871061

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

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.

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Key information

Conditions

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

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hakan Aygün

Izmir, 35575, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PENG block

Procedure

Pericapsular Nerve Group Block

Conventional opioid analgesia (Fentanyl)

Drug

standardised intravenous opioid

Primary outcomes

  1. Pain scores on the Numeric Rating Scale (NRS)

    Time frame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 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: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)

    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: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)

    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.

Sponsors and collaborators

Lead sponsor

Cigli Regional Training Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2021
Registry last updated
Apr 14, 2022

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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