NCT06183541

Brief Summary

In this study, it was aimed to compare the multimodal analgesia application or the pericapsular nerve group (PENG) block methods in patients undergoing hip surgery. The effectiveness and benefit rate of the PENG block in postoperative pain will be evaluated. Postoperative pain, need for additional analgesia, range of motion of the hip joint, mobilization time, length of hospital time and adverse events in patients undergoing hip fracture surgery with and without PENG block will be investigated.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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 21, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

December 3, 2023

Last Update Submit

November 16, 2025

Conditions

Keywords

PENG blockAnesthesia

Outcome Measures

Primary Outcomes (3)

  • postoperative pain score

    VAS pain score

    30 min, 12th, 24th and 48th hours in the postoperative period

  • Total opioid consumption

    Tramadol (mg)

    postoperative 48 hours

  • mobilisation time

    take 5 steps with walker

    postoperative 24-48 hours

Secondary Outcomes (2)

  • PENG block adverse events

    between the time surgery starts and the 48th hour

  • length of hospital stay

    between the time of hospitalization for the operation and discharge (day)

Study Arms (2)

PENG Block group

ACTIVE COMPARATOR

PENG block group; USG probe is placed on the transverse plane medial to the anterior inferior iliac spine (AIIS), the medial end of the probe is placed on the superior pubic It is rotated approximately 45° counterclockwise to align it with the ramus. For the PENG block, an 80 mm block needle is placed in the fascial plane between the psoas tendon and pubic ramus and 20 ml of 0.5% bupivacaine is administered after spinal anesthesia,

Procedure: Pericapsular Nerve Group (PENG) Block

Control group

OTHER

Control group; 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical area by the surgical team at the end of surgery

Procedure: Pericapsular Nerve Group (PENG) Block

Interventions

Pericapsular nerve group (PENG) block The femoral nerve and obturator nerve terminal branches, which provide sensory innervation of the hip joint, are blocked, thus providing analgesia without creating a motor block.

Control groupPENG Block group

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo hip fracture surgery Women and men aged 30-85

You may not qualify if:

  • Patients under 30 years old, over 85 years old
  • American Society of Anesthesiology (ASA) IV,
  • Those with cognitive impairment (alzheimer, dementia, delirium, etc.)
  • Those with application site infection
  • Those who are allergic to local anesthetic substances
  • Patients are non-consenting patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34734, Turkey (Türkiye)

RECRUITING

UmraniyeERH

Istanbul, Umraniye, 34734, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hip FracturesPain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Zeliha Tuncel, MD

    Umraniye Education and Research Hospita

    STUDY DIRECTOR

Central Study Contacts

Zeliha Tuncel, MD

CONTACT

Hale Arkan Tuna, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients who underwent PENG block and those who did not undergo PENG block are randomly divided into two groups using the sealed envelope method. They are grouped as Group I: Those who received PENG block (n: 35) and Group II: Those who did not receive PENG block (control group) (n: 35).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This prospective randomised controlled study included a total of 70 patients aged 30-85 years who underwent hip fracture surgery under spinal anaesthesia. Patients were divided into two groups as PENG block and non-PENG block (control group).
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 3, 2023

First Posted

December 27, 2023

Study Start

November 21, 2023

Primary Completion

December 30, 2025

Study Completion

January 30, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations