NCT05556759

Brief Summary

Approximately 1.66 million hip fractures happen in a year worldwide. About 95% of these fractures happen in individuals older than 60 years. Surgical treatment involving THA is considered the best option for patients with hip fractures and those with degenerative changes in the hip joint, especially in the elderly, however, it is associated with moderate to severe postoperative pain. Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesia techniques is of paramount importance. Moreover, early intervention of rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily. Effective pain management is one of the crucial components of enhanced recovery after surgery (ERAS). Numerous regional anesthetic techniques have been used to provide analgesia following THA, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, sacral plexus block, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA. Up to investigators' knowledge, there is no study done to compare the supra-iliac approach to the anterior QL block versus the Anterior iliopsoas muscle space block as pre-emptive analgesia in patients undergoing THA under general anesthesia

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

September 20, 2022

Last Update Submit

July 14, 2025

Conditions

Keywords

Anterior iliopsoas muscle space blocksuprailiac anterior quadratus lumborum blockanalgesiahip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • changes in Visual analogue scale (VAS)score

    On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain

    measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively

Secondary Outcomes (1)

  • Total dose of rescue analgesia

    in the first 24 hours postoperatively

Study Arms (3)

control group

PLACEBO COMPARATOR

patients will be operated on under general anesthesia

Procedure: control

IPS group

ACTIVE COMPARATOR

patients will receive an ultrasound-guided anterior iliopsoas muscle space (IPS) block

Procedure: IPS

Supra-iliac QL group

ACTIVE COMPARATOR

patients will receive an ultrasound-guided supra-iliac anterior quadratus lumborum (QL) block

Procedure: Supra-iliac QL

Interventions

controlPROCEDURE

patient will be operated under general anesthesia

control group
IPSPROCEDURE

patients will receive ultrasound-guided anterior IPS block with 30 ml of bupivacaine 0.25% followed by general anesthesia.

Also known as: anterior iliopsoas muscle space block
IPS group

patients will receive ultrasound-guided supra-iliac anterior QL block with 30 ml of bupivacaine 0.25% followed by general anesthesia.

Also known as: supra-iliac anterior quadratus lumborum block
Supra-iliac QL group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient acceptance.
  • Age 50-80 years old.
  • BMI ≤ 30 kg/m2
  • ASA I - III.
  • Elective total hip arthroplasty under general anesthesia.

You may not qualify if:

  • History of allergy to the LA agents used in this study
  • Skin lesion at the needle insertion site,
  • Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
  • Pre-existing neurological deficit in the lower extremity
  • History of chronic pain and taking analgesics
  • History of cognitive dysfunction or mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, zagazig university

Zagazig, Alsharqia, 4115, Egypt

RECRUITING

Related Publications (5)

  • Elsharkawy H, El-Boghdadly K, Barnes TJ, Drake R, Maheshwari K, Soliman LM, Horn JL, Chin KJ. The supra-iliac anterior quadratus lumborum block: a cadaveric study and case series. Can J Anaesth. 2019 Aug;66(8):894-906. doi: 10.1007/s12630-019-01312-z. Epub 2019 Mar 11.

    PMID: 30953311BACKGROUND
  • Dong J, Zhang Y, Chen X, Ni W, Yan H, Liu Y, Shi H, Jiang W, Zhao D, Xu T. Ultrasound-guided anterior iliopsoas muscle space block versus posterior lumbar plexus block in hip surgery in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):366-373. doi: 10.1097/EJA.0000000000001452.

    PMID: 33492871BACKGROUND
  • Chalacheewa, T, Termpornlert, S, Sa-Ngasoongsong P, Sangkum, Lisa. Regional Anesthesia for Hip Surgery Patients: Review Article. Journal of the Medical Association of Thailand 2022; 105: 152-9.

    BACKGROUND
  • Dangle J, Kukreja P, Kalagara H. Review of Current Practices of Peripheral Nerve Blocks for Hip Fracture and Surgery. Curr Anesthesiol Rep 2020; 10:259-66.

    BACKGROUND
  • Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.

    PMID: 27513972BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shereen E Abd Ellatif, MD

    Faculty of medicine, zagazig university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shereen E Abd Ellatif, MD

CONTACT

Naglaa F Abdelhaleem, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double-blinded(participants and outcome assessors)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The patients will be divided randomly by a computer-generated randomization table into three groups: Group C :(Control group) patients will be operated on under general anesthesia. Group IPS: patients will receive anterior IPS block with 30 ml of bupivacaine 0.25% followed by general anesthesia. Group Supra-iliac QL: patients will receive supra-iliac anterior QL block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of anesthesia and surgical intensive care

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 27, 2022

Study Start

September 30, 2022

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

planned after the completion of the study and publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
planned after the completion of the study and publication
Access Criteria
contact with principal investigator

Locations