NCT06573931

Brief Summary

This study aims to compare lumbar erector spinae plane block, fascia iliaca block, and lumbar plexus block for postoperative analgesia for hip surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

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

August 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

August 29, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

August 24, 2024

Last Update Submit

April 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to the 1st rescue analgesia

    Time to the first request for the rescue analgesia (time from end of block to first dose of morphine administrated) will be recorded.

    24 hours postoperatively

Secondary Outcomes (3)

  • Total morphine consumption in the 1st 24h

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

  • Incidence of adverse events

    24 hours postoperatively

Study Arms (3)

Lumbar Erector Spinae Plane Block

EXPERIMENTAL

Patients will receive lumbar erector spinae plane block at the end of surgery.

Other: Lumbar Erector Spinae Plane Block

Fascia Iliaca Block

EXPERIMENTAL

Patients will receive fascia iliaca block at the end of surgery.

Other: Fascia Iliaca Block

Lumbar Plexus Block

EXPERIMENTAL

Patients will receive lumbar plexus block at the end of surgery.

Other: Lumbar Plexus Block

Interventions

Patients will receive lumbar erector spinae plane block at the end of surgery.

Lumbar Erector Spinae Plane Block

Patients will receive fascia iliaca block at the end of surgery.

Fascia Iliaca Block

Patients will receive lumbar plexus block at the end of surgery.

Lumbar Plexus Block

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-III.
  • Undergoing total hip arthroplasty under spinal anesthesia.

You may not qualify if:

  • Obesity (Body Mass Index \> 30 kg/m2).
  • Allergy to any drug used in the study.
  • Contraindications to spinal anesthesia (such as Thrombocytopenia (platelets \<100,000/mCL) and coagulopathy (INR \>1.4 or insufficient time since stopping systemic anticoagulation)).
  • Epilepsy.
  • Psychiatric disease.
  • Pre-existing neurologic deficits or neuropathies.
  • Pregnancy.
  • Pre-existing alcohol/opioid use disorder.
  • Previously diagnosed with chronic pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

August 24, 2024

First Posted

August 27, 2024

Study Start

August 29, 2024

Primary Completion

February 15, 2025

Study Completion

February 15, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations