NCT03783247

Brief Summary

In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

December 18, 2018

Last Update Submit

December 19, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    total morphine consumption over 24 hours

    24 hours

Secondary Outcomes (2)

  • pain scale Visual analogue Scale

    24hours

  • muscle power

    24 HOURS

Study Arms (2)

FIB

EXPERIMENTAL

hip fracture with fascia Iliaca block

Procedure: Fascia Iliaca BLock

PENG

EXPERIMENTAL

Hip fracture with Pericapsular nerve group block

Procedure: Pericapsular nerve group block

Interventions

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 (Figs. 2, 3). 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 (20ml of bupivacaine 0.25%) was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 30 mL

Also known as: PENG
PENG

In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest \& iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.

Also known as: FIB
FIB

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for hip replacement surgeries e.g. hip hemiarthroplasty, total hip arthroplasty under subarachnoid block (SAB)

You may not qualify if:

  • Coagulopathy
  • infection at the injection site
  • allergy to local anesthetics
  • severe cardiopulmonary disease (≥ASA IV)
  • diabetic or other neuropathies
  • patients receiving opioids for chronic analgesic therapy
  • contraindication to spinal anesthesia
  • inability to comprehend visual analog scale (VAS).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 1234, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
To achieve double blinding, patients will receive the block by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperatively.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized double-blinded
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

December 18, 2018

First Posted

December 21, 2018

Study Start

February 15, 2019

Primary Completion

May 31, 2019

Study Completion

June 20, 2019

Last Updated

December 21, 2018

Record last verified: 2018-12

Locations