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

NCT04871061 | Completed

• 1 other identifier: PENG55
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute

Keywords

hip fracture, postoperative analgesia, positioning pain

Outcome Measures

Primary Outcomes (1)

• 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").

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

Secondary Outcomes (3)

• Duration of spinal anesthesia performance

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

• Quality of patient's position

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

• Analgesic consumption

  24 hours

Study Arms (2)

PENG Block

ACTIVE COMPARATOR

For patients with hip fracture and having hip surgery this study evaluates the analgesic effects of Pericapsular Nerve Group (PENG) block for positioning before spinal anesthesia.

Procedure: PENG Block

Control

ACTIVE COMPARATOR

in this group, standardised opioid doses (drug: Fentanyl) will be used for analgesia for positioning pain

Drug: Conventional opioid analgesia (Fentanyl)

Interventions

PENG Block PROCEDURE

Pericapsular Nerve Group Block

PENG Block

Conventional opioid analgesia (Fentanyl) DRUG

standardised intravenous opioid

Control

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hip fracture
• aged between 35 and 90 years old

You may not qualify if:

• contraindications for spinal anesthesia and PENG block
• impaired cognition or dementia
• multiple fractures
• any previous analgesic administration during the last 12 hours

Sponsors & Collaborators

• Cigli Regional Training Hospital: lead

Study Sites (1)

Hakan Aygün

Izmir, 35575, Turkey (Türkiye)

Location

Related Publications (2)

• Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.

  PMID: 25068412 RESULT

• Aygun H, Tulgar S, Yigit Y, Tasdemir A, Kurt C, Genc C, Bilgin S, Senoglu N, Koksal E. Effect of ultrasound-guided pericapsular nerve group (PENG) block on pain during patient positioning for central nervous blockade in hip surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Sep 15;23(1):316. doi: 10.1186/s12871-023-02245-3.

  PMID: 37715173 DERIVED

MeSH Terms

Conditions

Acute Pain; Hip Fractures

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hakan Aygun, MD

  Cigli RTH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated randomization codes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 4, 2021
• Study Start: May 6, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 5, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

TU (1)