NCT05941221

Brief Summary

the goal of this clinical trial is to evaluate the analgesic effect of pericapsular nerve group (PENG) block in elderly patients with hip fractures undergoing hip surgery . and to evaluate its effect in reducing post operative complications .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

June 24, 2023

Last Update Submit

July 3, 2023

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • post operative analgesic effect of PENG block

    evaluate the analgesic effect of PENG block in the post operative period both at rest and with movement using the Visual analog scale for pain

    24 hours

Secondary Outcomes (1)

  • post operative complications

    24 hours

Study Arms (1)

study group

EXPERIMENTAL

patients will receive pericapsular nerve group (PENG )block through ultrasound at the end of the surgery.

Procedure: pericapsular nerve group (PENG) block

Interventions

pericapsular nerve group (PENG) blockPROCEDURE

patients will receive PENG block through ultrasound. The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed . A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL bupivacaine 0.25%.

study group

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients must age 60 years or more .
  • patients must belong to american society of anesthesiologists (ASA) classification class II or III

You may not qualify if:

  • age \< 60 years
  • ASA IIII
  • refusal of peripheral nerve block
  • infection at the site of injection
  • coagulopathy INR \> 1.8
  • platelets count \< 50,000
  • known allergy to used medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

RECRUITING

Related Publications (2)

  • Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2.

    PMID: 35933328BACKGROUND

  • Ying H, Chen L, Yin D, Ye Y, Chen J. Efficacy of pericapsular nerve group block vs. fascia iliaca compartment block for Hip surgeries: A systematic review and meta-analysis. Front Surg. 2023 Feb 10;10:1054403. doi: 10.3389/fsurg.2023.1054403. eCollection 2023.

    PMID: 36843984BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Lydia E Zakhary, MD

CONTACT

00201222555128lydia_zakhary@med.asu.edu.eg

samuel H Daniel, MD

CONTACT

00201224394897

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 12, 2023

Study Start

March 30, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations

EG(1)