NCT06839742

Brief Summary

The researchers aimed to compare the effects of adding a Deep Posterior Gluteal Compartment Block to a Suprainguinal Fascia Iliaca Compartment Block (SFICB) versus SFICB alone on pain, analgesic consumption, and positioning pain for neuraxial anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

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

December 11, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 6, 2026

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

December 11, 2024

Last Update Submit

January 5, 2026

Conditions

Keywords

acute pain managementhip surgeryDeep posterior gluteal compartment blockSuprainguinal fascia iliaca plane block

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.

    24 hours

Secondary Outcomes (4)

  • Perioperative pain intensity

    24 hours

  • Quality of recovery 15 scale

    24 hours after surgery

  • Quality of patient's position for neuraxial anesthesia

    up to ten minutes

  • Quadriceps weakness

    24th hours

Study Arms (2)

Group SFICB

ACTIVE COMPARATOR

Suprainguinal fascia iliaca plane block will be performed 30 minutes before hip surgery

Other: Suprainguinal fascia iliaca compartment block

Group Combined

ACTIVE COMPARATOR

Suprainguinal Fascia İliaca plane Block will be performed 30 minutes before hip surgery and Deep Posterior Gluteal Compartment Block will be performed 20 minutes before hip surgery

Other: Deep Posterior Gluteal Compartment BlockOther: Suprainguinal fascia iliaca compartment block

Interventions

Suprainguinal fascia iliaca compartment block will be performed under USG guidance before neuraxial anesthesia.

Group CombinedGroup SFICB

Deep Posterior Gluteal Compartment Block will be performed under USG guidance before neuraxial anesthesia.

Group Combined

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the study
  • Patients between the ages of 18-90
  • ASA I, II, III
  • Patients whose surgery duration does not exceed 2 hours
  • Patients who will undergo surgery under spinal anesthesia

You may not qualify if:

  • Patients who do not want to participate in the study/do not give consent
  • Patients with a condition that prevents regional anesthesia
  • Patients with cognitive dysfunction who are unable to evaluate the NRS score and who cannot use PCA (Patient Controlled Analgesia Device)
  • History of hypersensitivity or allergy to local anesthetics
  • Patients with psychiatric disorders and those using psychiatric medications
  • Presence of hematological disease
  • Presence of oncological disease
  • Patients with serious major organ failure
  • Presence of multiple fractures
  • Patients with alcohol or drug addiction
  • Patients who have used analgesic drugs up to 12 hours before surgery
  • ASA IV-V patients
  • Morbidly obese patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadım, Turkey (Türkiye)

Location

Related Publications (3)

  • Safa B, Trinh H, Lansdown A, McHardy PG, Gollish J, Kiss A, Kaustov L, Choi S. Ultrasound-guided suprainguinal fascia iliaca compartment block and early postoperative analgesia after total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Jul;133(1):146-151. doi: 10.1016/j.bja.2024.04.019. Epub 2024 May 18.

    PMID: 38762396BACKGROUND
  • Roche JJ, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. BMJ. 2005 Dec 10;331(7529):1374. doi: 10.1136/bmj.38643.663843.55. Epub 2005 Nov 18.

    PMID: 16299013BACKGROUND
  • Vermeylen K, Van Aken D, Versyck B, Casaer S, Bleys R, Bracke P, Groen G. Deep posterior gluteal compartment block for regional anaesthesia of the posterior hip: a proof-of-concept pilot study. BJA Open. 2023 Feb 15;5:100127. doi: 10.1016/j.bjao.2023.100127. eCollection 2023 Mar.

    PMID: 37587997BACKGROUND

Study Officials

  • HATİCE SELÇUK KUŞDERCİ

    SAMSUN UNİVERSITY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2024

First Posted

February 21, 2025

Study Start

February 24, 2025

Primary Completion

December 15, 2025

Study Completion

December 31, 2025

Last Updated

January 6, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Locations