NCT05023473

Brief Summary

The pericapsular nerve group block (PENG) is a regional anaesthetic technique that was developed in 2018, primarily for total hip arthroplasties (THA) as a postoperative analgesia modality with motor sparing benefits. The block is thought to provide more complete analgesia to the hip by depositing local anaesthetic within the myofascial plane of the psoas muscle and superior pubic ramus. In this study, the investigators will assess the effect of pericapsular nerve group (PENG) block on pain control in patients with proximal femur fracture in the emergency department. The Control group will receive morphine as regular patient control analgesia (PCA) The interventional group will receive PENG block before being attached to regular morphine PCA

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

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

August 14, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

August 14, 2021

Last Update Submit

September 12, 2022

Conditions

AnalgesiaFemur Fracture

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    compare the total morphine consumption in milligrams that is given by patient-controlled analgesia device (PCA)

    immediately at the end of 24 hours

Secondary Outcomes (2)

  • Numeric rating scale (NRS)

    immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest

  • Incidence of nausea and vomiting

    immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest

Study Arms (2)

PENG block+ morhine

ACTIVE COMPARATOR

the participants will receive PENG block before being attached to morphine PCA

Procedure: Pericapsular nerve group blockDrug: Morphine Sulfate

MORPHINE

ACTIVE COMPARATOR

The participants will be given morphine PCA without PENG block

Drug: Morphine Sulfate

Interventions

Pericapsular nerve group blockPROCEDURE

patients will receive pericapsular nerve group block

PENG block+ morhine
Morphine SulfateDRUG

morphine will be given to both groups as patient-controlled analgesia PCA

MORPHINEPENG block+ morhine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are aged 18-70 years.
  • Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status grade II) = (patients with mild systemic disease and no functional limitations).
  • Patients having post-traumatic pain associated with fractures of the proximal femur or femoral head.

You may not qualify if:

  • Patient refusal to participate in the study
  • Known allergy to LA.
  • Body mass index (BMI) more than 40 kg/m2
  • Heart block greater than first degree
  • Renal, and hepatic dysfunction
  • Underlying coagulopathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, 41511, Egypt

Location

MeSH Terms

Conditions

AgnosiaFemoral Fractures

Interventions

Morphine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsFractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and intensive care

Study Record Dates

First Submitted

August 14, 2021

First Posted

August 26, 2021

Study Start

April 1, 2022

Primary Completion

August 15, 2022

Study Completion

September 1, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations

EG(1)