NCT05817916

Brief Summary

The aim is to clinical trials compare the lumbar plexus block method with the erector spinae plan block method in terms of analgesic efficacy and possible complications. İn patients for femur fracture surgery. The main questions it aims to answer are: 1. is erector spinae plane block as effective as lumbar plexus block for postoperative analgesia in femur fractures? 2. Is erector spinae plane block effective for reducing opioid consumption compared to lumbar plexus block?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

January 23, 2023

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    Opioid consumption will be measured in micrograms.

    postoperative 24 hours

Study Arms (2)

ESP Block

ACTIVE COMPARATOR
Procedure: ESP block

LP block

ACTIVE COMPARATOR
Procedure: LP block

Interventions

ESP blockPROCEDURE

ESP block: ultrasound guided erector spina plane block

ESP Block
LP blockPROCEDURE

LP block: ultrasound guided lumbar plexus block

LP block

Eligibility Criteria

Age45 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Proximal femoral surgery
  • All patients who can respond to pain assessment questions

You may not qualify if:

  • Regional block contraindications,
  • Severe cardiac and respiratory disease,
  • Severe coagulopathy,
  • Body mass index greater than 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Hospital

Sakarya, Turkey (Türkiye)

Location

Related Publications (2)

  • Badiola I, Liu J, Huang S, Kelly JD 4th, Elkassabany N. A comparison of the fascia iliaca block to the lumbar plexus block in providing analgesia following arthroscopic hip surgery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:26-29. doi: 10.1016/j.jclinane.2018.05.012. Epub 2018 Jun 1.

  • Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group 1: The patients in the first group (ESP Group) will be applied ultrasound guided ESP block at the lateral position at the end of the surgery. ESP will be performed with a posterior approach, under ultrasound guidance, by imaging the muscles and the needle. Group 2: At the end of the surgery, patients in the second group (LP Group) will have an appropriate level of LP block with ultrasound guidance and, if necessary, using a neurostimulator.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

April 18, 2023

Study Start

April 15, 2023

Primary Completion

October 15, 2023

Study Completion

November 15, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations