NCT05050487

Brief Summary

Pain is a major problem that has to be dealt with in case of hip fracture, as it presents an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy. With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects Lumbar erector spinae plane block has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

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

September 10, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

September 10, 2021

Last Update Submit

April 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Duration of analgesia

    the time passed from block to the patient's first analgesic request in hours

    24 hour

Study Arms (2)

treatment

EXPERIMENTAL

patient will recieve pericapsular nerve group block

Procedure: PENG block

treatement

EXPERIMENTAL

patient will receive lumbar erector spinae plane block

Procedure: lumbar erector spinae plane block

Interventions

PENG blockPROCEDURE

The PENG block is performed under US guid¬ance, . The pa¬tient is placed in the supine position a curvilinear low-fre¬quency ultrasound probe (2-5 MHz) is initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe approximately 30-45 degrees . . The needle, usually a 22-G80-mm echogenic device, is inserted from lateral to medial with an in-plane approach to place the tip in the plane between the psoas tendon anteriorly and the pu¬bic ramus posteriorly . After needle insertion and following negative aspiration, the local anesthetic is injected . The volume used of 20 ml of(L-bupivacaine; concentration 0,25% ) . This fascial plane appeared to continue in the hip pericapsular plane.

Also known as: pericapsular nerve group block
treatment

The lumbar erector spinae block is performed under US guid¬ance, after adequate skin disinfection The patient is placed in the lateral decubitus position according to the selected site of surgical intervention. The 4th lumbar vertebral level will determined The convex USG transducer was placed at the mid-vertebral line in the sagittal plane. The transducer was shifted from the midline, 3.5-4 cm laterally to the side of the surgery to visualize the erector spinae muscle and transverse process . 0.5-1 ml of the prepared LA solution (20 ml bupivacaine 0.25%). All LA was administered to this location between the transverse process and the erector spinae muscle.

Also known as: ESPB
treatement

Eligibility Criteria

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

You may qualify if:

  • ASA grade 1\&2 \&3
  • Adult patients (Age \>18 yrs)
  • Eligible patients were aged 18 years or older, were admitted for hip arthroplasty (THA or HA) for femoral neck fracture, and had undergone a preoperative RA technique (PENG block or lumbar erector spinae plane block)

You may not qualify if:

  • Patients with chronic pain before surgery (taking opioids)
  • Patients with multiple trauma
  • Patients who could not assess pain reliably (dementia)
  • Patients who in anticoagulation
  • Patient refused
  • Infection at the side of injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled trail
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer of anesthesia and intensive care

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 20, 2021

Study Start

June 30, 2022

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

April 28, 2022

Record last verified: 2022-04