NCT06813755

Brief Summary

Hip fracture surgery is a common orthopedic procedure, especially in elderly patients. These fractures are quite common in adults over the age of 65, and the one-year mortality rate ranges from 12% to 37%. Recent studies have suggested that general anesthesia and spinal anesthesia are not superior to each other in patients undergoing hip fracture surgery. Untreated/poorly managed perioperative pain is directly linked to delirium, poor prognosis, and secondary chronic pain in hip fracture patients. Therefore, considering the associated mortality, morbidity, and early recovery, control of perioperative pain should be one of the highest priorities of the anesthesiologist, regardless of the anesthesia method used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

December 9, 2024

Last Update Submit

May 27, 2025

Conditions

Keywords

peng blockregional anesthesiageriatric population

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 ketamine), Group B: 20 minutes after intervention (PENG block)

  • Quality of patient's position

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

  • Analgesic consumption

    24 hours

Study Arms (2)

Procedure: PENG Block Pericapsular Nerve Group Block

Active Comparator: PENG Block 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.

Drug: Conventional intravenous sedoanalgesia (ketamine) standardised intravenous sedoanalgesia agent

Active Comparator: Control in this group, standardised sedoanalgesia doses (drug: ketamine) will be used for analgesia for positioning pain

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 60 participants older than the age of 40 who will undergo hip fracture surgery under spinal anesthesia will be included in the study.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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: 37715173BACKGROUND

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

December 9, 2024

First Posted

February 7, 2025

Study Start

November 20, 2024

Primary Completion

May 20, 2025

Study Completion

May 26, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations