NCT07240961

Brief Summary

The Erector Spinae Plane (ESP) block or spinal erector block was first described in September 2016 by a Canadian team. It's a block that was initially used for the treatment of chronic thoracic neuropathic pain. The ESP block is one of the inter-fascicular blocks and it's an easy-to-perform technique.In the literature, it has been reported that Lumbar ESPB provides effective analgesia after a hip surgery. The purpose of this prospective randomized study was to compare the analgesic effects of the ultrasound-guided lumbar Erector Spinae Plane block on postoperative pain management versus the multimodal analgesia after total hip arthroplasty.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Nov 2025

Shorter than P25 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

Study Progress76%
Nov 2025Jul 2026

First Submitted

Initial submission to the registry

May 1, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2026

Last Updated

November 21, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 1, 2025

Last Update Submit

November 16, 2025

Conditions

Keywords

hip arthroplastyLumbal Erector Spinae Plane Blockpain managment

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    total morphine dose

    Day 1

Secondary Outcomes (6)

  • pain scores

    Hour 2, Hour 4, Hour 6, Hour 12, Hour 18, Hour 24 and on Day 2 and Day 7.

  • intraoperative opioid consumption

    end of surgery

  • pain on sitting position

    Day 1

  • QR 9 score

    Day 2

  • ROM

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

hip arthroplasty with nerve block

ACTIVE COMPARATOR

Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block

Procedure: Lumbal Erector Spinae Plane Block

hip arthroplasty with intravenous pain killers

PLACEBO COMPARATOR

intravenous pain killers

Procedure: intravenous pain killers

Interventions

Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block.

hip arthroplasty with nerve block

intravenous pain killers

hip arthroplasty with intravenous pain killers

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary total hip arthroplasty with lateral approach and under general anesthesia .

You may not qualify if:

  • Contraindication or refusal to regional anesthesia
  • Contraindication to non-steroidal anti-inflammatory (NSAID's)
  • Allergy to opioids
  • Allergy to paracetamol
  • Creatinine clearance \< 30ml/min
  • Weight\<50 kg or \>100kg
  • Psychiatric disorders and difficulty of communication
  • Lower limb neurological deficit
  • Patients undergoing bilateral or revision total hip replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kassab Orthopedic Institute

Manouba, 2010, Tunisia

RECRUITING

Central Study Contacts

KAABACHI OLFA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 1, 2025

First Posted

November 21, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 7, 2026

Last Updated

November 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations