NCT06003738

Brief Summary

The aim of this study is to compare the effectiveness of pericapsular nerve group (PENG) block versus fascia iliaca compartment block (FICB) for postoperative pain relief following total hip arthroplasty (THA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

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

First Submitted

Initial submission to the registry

July 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

July 12, 2023

Last Update Submit

August 11, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Degree of pain

    Degree of pain was assessed using the Visual Analogue Scale (VAS). VAS is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain. VAS was recorded at 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.

    24 hours postoperatively

  • Total amount of nalbuphine consumption

    If the postoperative Visual Analogue Scale (VAS) was greater than 3, an intravenous dose of 5 mg Nalbuphine diluted in 5 mL of saline was administered as needed.

    24 hours postoperatively

  • Number of cases needing rescue doses

    The number of cases needing rescue doses was recorded.

    24 hours postoperatively

Secondary Outcomes (1)

  • Postoperative ambulation

    24 hours postoperatively

Study Arms (2)

Group A

EXPERIMENTAL

Patients received an ultrasound-guided supra-inguinal fascia iliaca compartment block.

Other: Fascia iliaca compartment block

Group B

ACTIVE COMPARATOR

Patients received an ultrasound-guided pericapsular nerve group (PENG) block.

Other: Pericapsular nerve group block

Interventions

Patients received an ultrasound-guided supra-inguinal fascia iliaca compartment block.

Group A

Patients received an ultrasound-guided pericapsular nerve group (PENG) block.

Group B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 80 years.
  • Both sexes.
  • American Society of Anaesthesiologists (ASA) Physical Status II-III.
  • Scheduled for Total hip arthroplasty (THA) under spinal anesthesia.

You may not qualify if:

  • Patients' refusal
  • Contraindications to spinal anesthesia or nerve blocks.
  • History of allergy to the medications used in the study.
  • Pregnancy.
  • Significant cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams University

Cairo, 11588, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia

Study Record Dates

First Submitted

July 12, 2023

First Posted

August 22, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations