NCT07003633

Brief Summary

The aim is to provide effective preoperative analgesia in patients undergoing surgical procedures due to hip fractures by administering a pericapsular nerve group (PENG) block under ultrasound guidance. This approach seeks to increase patient satisfaction, reduce analgesic requirements, enable earlier discharge, and decrease morbidity and mortality.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jun 2025Jun 2026

First Submitted

Initial submission to the registry

May 15, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 15, 2025

Last Update Submit

May 26, 2025

Conditions

Keywords

AnalgesiaPENG blockHip Fracture

Outcome Measures

Primary Outcomes (1)

  • Preoperative Pain Scores and Opioid Consumption

    Preoperative pain of patients will be assessed with NRS (Numeric Raitng Scale) which ranges from 0 (no pain) to 10 (the most severe pain imaginable).

    24 hours preoperatively

Secondary Outcomes (3)

  • Discharge Time

    From surgery to discharge up to 30 days

  • Postoperative Mortality and Morbidity

    30 days after surgery

  • Opioid Consumption

    24 hours preoperatively

Study Arms (2)

Group PENG

EXPERIMENTAL

Group PENG will involve the patients who will be performed PENG block 24 hours before surgery.

Procedure: PENG block with 0.25% bupivacaine guided by ultrasound.

Group Control

NO INTERVENTION

Group Control will involve the patients who will not be performed PENG block preoperatively.

Interventions

PENG (Pericapsular nerve block) is a peripheral nerve block which is performed for patients with hip fractures aimed to prevent preoperative and postoperative pain. It is performed under sterile conditions under ultrasound guideance.

Group PENG

Eligibility Criteria

Age45 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing hip farcture surgery

You may not qualify if:

  • Chronic analgesics consumption
  • Patients contraindicated for neuraxial anesthesia
  • Alcohol and drug addiction
  • Allergies to local anesthetics and opioids
  • Patients who refuses to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Universtiy Training and Research Hospital

Sakarya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaHip Fractures

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Central Study Contacts

Alim Miniksar, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients will be randomized to their rescpective groups with closed envelope method.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Resident, M.D.

Study Record Dates

First Submitted

May 15, 2025

First Posted

June 4, 2025

Study Start

June 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations