Lumbal Erector Spinae Plane Block for Pain Management After Total Hip Arthroplasty

NCT ID: NCT07240961

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-07-07

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.

Detailed Description

Patients aged more than 18 years, ASA I-III scheduled for primary total hip arthroplasty with lateral approach and under general anesthesia Patients were randomly assigned, into 1 of 2 groups, namely, group ESPBL and group Placebo, using sealed envelopes

• For ESPBL group: 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.
• For Placebo group: patients had multimodal analgesia without lumbar ESP block Patients will be transferred to continuous care unit for 24 hours.

Post-operative analgesia will include:

1. Paracetamol 1g IV every 8 hours for 1 day then oral paracetamol 1g every 8 hours for 4 weeks.

2. Diclofenac sodium(50mg) 1 tablet x 2 per day for 5 days.

3. PCA morphine (Patient Controlled Analgesia), as a rescue analgesia, programmed as: Bolus of 1mg/ refractory period of 10 min/ maximum dose set up at 10mg every 12h.

The primary outcome of the study is to compare postoperative opioids consumption in the first 24 postoperative hours.

Secondary endpoints:

Secondary outcomes are: intraoperative opioid consumption, postoperative pain scores, sitting position and adverse effects related to opioids.

Conditions

Total Hip Arthroplasty (THA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

hip arthroplasty with nerve block

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

Group Type: ACTIVE_COMPARATOR

Lumbal Erector Spinae Plane Block

Intervention Type: PROCEDURE

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 intravenous pain killers

intravenous pain killers

Group Type: PLACEBO_COMPARATOR

intravenous pain killers

Intervention Type: PROCEDURE

intravenous pain killers

Interventions

Lumbal Erector Spinae Plane Block

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.

Intervention Type: PROCEDURE

intravenous pain killers

intravenous pain killers

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Olfa kaabachi, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kassab Orthopedic Institute

Manouba, , Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

KAABACHI OLFA

Role: CONTACT

Facility Contacts

KAABACHI OLFA OLFA, PROFESSOR

Role: primary

olfa.kaabach@gmail.com

0021098317381

Other Identifiers

IMKO-CE 115/2024

Identifier Type: -

Identifier Source: org_study_id