NCT06183528

Brief Summary

The hypothesis of this study is that patients who undergo PENG block in before Total Hip Artroplasthy (THA) surgery with spinal anesthesia will have reduced postoperative pain scores, less need for opioid analgesics and earlier mobilisation.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

November 30, 2023

Last Update Submit

November 16, 2025

Conditions

Keywords

Multimodal analgesiapericapsular nerve group blocktotal hip arthroplastyspinal anesthesia

Outcome Measures

Primary Outcomes (4)

  • postoperative pain score

    VAS pain score

    recovery room 30 min, 12., 24. and 48. hours in the postoperative period

  • mobilisation time

    walking 5 steps with walker

    24 -48 hours

  • hip joint patency

    Measurement of joint movement angle with goniometer (angle)

    24. hours

  • total opioid consumption

    Tramadol total usage (mg)

    48 hours

Secondary Outcomes (3)

  • PENG block side effects

    The first 48 hours after performing the PENG block

  • Perioperative haemodynamic data

    T1: 30 minutes (min) after spinal anesthesia, T2: at the end of the surgical procedure, T3: at 30 minutes after recovery

  • length of hospital stay

    day

Study Arms (2)

PENG group

ACTIVE COMPARATOR

PENG block was placed in the fascial plane between the pseudotendon and pubic ramus with USG in-plane technique, 20 ml of 0.5% bupivacaine was administered after spinal anaesthesia.

Procedure: Pericapsular Nerve Group (PENG) Block

non-PENG group

PLACEBO COMPARATOR

group non-PENG, surgery was started without PENG block after spinal anaesthesia.

Procedure: Pericapsular Nerve Group (PENG) Block

Interventions

With ultrasonography-guided PENG block, the femoral, obturator and accessory obturator nerve branches that provide sensory innervation of the anterior surface of the hip joint capsule are blocked .

PENG groupnon-PENG group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • THA performed by posterior approach
  • age range
  • ASA 1-3

You may not qualify if:

  • Under 40 years of age, over 85 years of age,
  • ASA 4 and above,
  • Cognitive impairment (Alzheimer's disease, dementia, delirium etc.),
  • Hip fracture,
  • Application site infection,
  • Allergy to local anaesthetic agents,
  • Patients are non-consenting patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UmraniyeERH

Istanbul, Umraniye, 34734, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • zeliha tuncel

    Ümraniye Training and Education hospital

    STUDY DIRECTOR

Central Study Contacts

zeliha tuncel, ass prof

CONTACT

hale arkan tuna, specialist dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This prospective randomised controlled study included a total of 60 patients aged 40-85 years who underwent THA 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
Ass prof

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 27, 2023

Study Start

September 1, 2023

Primary Completion

October 10, 2024

Study Completion

December 30, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations