NCT06916000

Brief Summary

to study the effect of Pericapsular nerve group (PENG) block as a part of multimodal analgesia regimen for hip arthroplasties

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not 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

June 27, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 8, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

November 28, 2024

Last Update Submit

April 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain score: pain assessment using a Numeric Rating System (NRS) immediately in the postoperative period.

    Pain score: pain intensity will be evaluated using a Numeric Rating System (NRS) immediately in the postoperative period, every 2 hours during the first 6 hours and then every 6 hours till 24 hours postoperatively. Scores ranging from 0 to 10, with 0 indicating the absence of pain and 10 indicating the worst possible pain.

    24 hours

Secondary Outcomes (1)

  • Rescue analgesia timing and opioid consumption over 24 hours

    24 hours

Study Arms (2)

PENG block group (25 particiants)

ACTIVE COMPARATOR

For postoperative pain management, all patients of this arm will receive 20 ml of 0.25% bupivcacaine according to the technique described by Giron-Arango. In addition, multimodal analgesia will be given including IV paracetamol 1000 mg BID and oral celecoxib tablet 100 mg BID. Also if needed nalbuphine 5 mg IV will be given as demand dose and when the NRS pain score was equal to or greater than 4 points.

Drug: Pericapsular nerve group (PENG) block

Group C: control group (25 participants)

EXPERIMENTAL

Patients will receive only other multimodal analgesics

Other: Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine.

Interventions

As a part of multimodal analgesia patients will receive 20 ml of 0.25% bupivcacaine according to the technique described by Giron-Arango. All patients will receive the same analgesic protocol, which included IV paracetamol 1000 mg BID and NSAIDs if no contra-indication; PO celecoxib 100 mg BID. Also if needed nalbuphine 5 mg IV will be given as bolus demand dose and when the NRS pain score was equal to or greater than 4 points.

PENG block group (25 particiants)

Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine.

Group C: control group (25 participants)

Eligibility Criteria

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

You may qualify if:

  • Age group: 18 years and older.
  • ASA classification I to III.
  • BMI : 18-35 .
  • Gender: both sex

You may not qualify if:

  • Patient refusal.
  • Patients on long-term pain medications.
  • History of allergic reactions to local anesthetics
  • Patients who had mental illness or uncooperative patients.
  • BMI \> 35 .
  • Patients having coagulopathies or on anticoagulant or antiplatelet therapy.
  • Severe cardiopulmonary disease
  • ASA IV or more
  • Diabetic or other neuropathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Ain Shams University

Abbasia, Cairo Governorate, 11517, Egypt

Location

MeSH Terms

Interventions

Dental OcclusionBupivacaine

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

April 8, 2025

Study Start

June 27, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

April 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations