NCT04336059

Brief Summary

Peripheral nerve blocks are becoming increasingly popular for hip surgery anesthesia. Modern regional anesthesia for major hip surgery includes the use of a single shot and continuous epidural or spinal injections, continuous lumbar plexus blockade and continuous peripheral blockade of the femoral nerve (FN), fascia iliaca (FI) block, 3-in-1 FN block and sciatic nerve. The use of either single shot or continuous peripheral nerve blocks are becoming increasingly popular. This study will be conducted to evaluate the effect of ultrasound guided pericapsular nerve group block in hip arthroplasty surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

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

April 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 17, 2021

Status Verified

December 1, 2020

Enrollment Period

7 months

First QC Date

April 3, 2020

Last Update Submit

February 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • first time of rescue analgesia.

    first time of rescue morphine analgesia.

    postoperative first day

Secondary Outcomes (2)

  • postoperative morphine consumption

    postoperative first day

  • pain score

    postoperative first day

Study Arms (2)

group 1

OTHER

will receive sham PENG block with normal saline in total volume of 20 ml.

Procedure: pericapsular nerve group block

group 2

EXPERIMENTAL

will receive real PENG block with bupivacaine (0.25%) in total volume of 20 ml.

Procedure: pericapsular nerve group block

Interventions

The regional block will be performed with the patient in the supine position under complete sterile technique. A low frequency curvilinear ultrasound probe will be initially placed in a transverse plane over the anterior inferior iliacspine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminance(IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will observed. A 22-gauge, 80-mm needle will be 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 after local infiltration of the site of the block with 3 ml lidocaine 2%. Following negative aspiration,the normal saline solution will injected in 5-mL increments while observing for adequate fluid spread in this plane.

group 1group 2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will involve in the research if they will schedule for unilateral hip arthroplasty (THA) surgery.
  • aged more than 50 years of both genders.
  • have American society of anesthiologists physical status I-II and III.

You may not qualify if:

  • Revision hip arthroplasty.
  • hip arthroplasty. combined with subtrochanteric shortening osteotomy.
  • drug allergy.
  • regular narcotic use.
  • renal \&/ or hepatic impairments.
  • coagulopathy disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 7, 2020

Study Start

May 1, 2020

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

February 17, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations