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Completed

NCT Number: NCT06282666

Lumbar ESPB in Hip Replacement Surgery

In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed.

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Key information

Conditions

Coxarthrosis Acute Pain Agnosia Analgesia Anesthesia Arthritis Chronic Pain Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis Osteoarthritis, Hip Pain Pain, Acute Pain, Chronic Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain, Chronic Quality of Life Rheumatic Diseases Signs and Symptoms Spinal

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

II Department of Anesthesia and Intensive Care

Lublin, 20-081, Poland

About this study

This is a prospective trial in patients undergoing elective hip replacement surgery.

Written informed consent will be obtained from each patient, and our study will be conducted following the tenets of the Declaration of Helsinki for medical research involving human subjects.

Before the surgery, preoperative pain severity, chronic pain severity, and ability to sit, stand, and walk will be assessed.

Each participant will be anesthetized with spinal technique and randomly allocated patients according to postoperative analgesia to the continuous epidural (Epidural) group and the continuous lumbar erector spinae plane block (ESPB) group. Both regional techniques will be continued during the first day. Investigators will measure postoperative oxycodone consumption with a patient-controlled analgesia (PCA) pump. At several points, the patients' pain at rest and during activity will be evaluated on the visual analog scale (VAS, 0-10), their quadriceps femoris muscle strength on the Lovett scale (0-5), and their ability to sit, stand upright, and walk on the Timed Up and Go test. Moreover, the patient's recovery will be assessed through the Quality of Recovery 40 (QoR-40) questionnaire on the first postoperative day.

After the patient's discharge, information regarding acute and chronic pain severity and quality of recovery will be collected during the phone interview.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary hip replacement surgery due to coxarthrosis
  • anesthetized with spinal technique
  • able to use PCA pump
  • having access to phone

Exclusion criteria

  • patients taking painkillers not related to coxarthrosis;
  • having active cancer,
  • dementia or challenging contact with the patient;
  • suffering from depression or other psychiatric disorders that required antidepressant treatment;
  • consuming alcohol or recreational drug addiction;
  • contraindications to the regional block.

Treatment and study plan

Spinal anesthesia

Procedure

Before the beginning of surgery, all patients will be anesthetized with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 1.5 - 2.5 mL solution. A pencil point spinal needle will be used.

Other names: Subarachnoid anesthesia

Lumbar Erector Spinae Plane Block

Procedure

Investigators will perform the lumbar ESPB under ultrasound control at the L3 level on the ipsilateral site of the surgery. After dissection with 0.9 NaCl, we will leave a catheter in the ESP. Then, we used 0.25% bupivacaine with epinephrine (5mcg/mL), 0.4 mL per kg, up to 40 mL.

Other names: ESPB

Epidural Analgesia

Procedure

After identifying the epidural space and spinal anesthesia (combined technique), a catheter will be placed in the epidural space. Investigators will give an epidural catheter a test dose of 2% lidocaine (2 mL). At the end of the surgery, the patient will receive 5 mL of a mixture containing 0.1% bupivacaine with fentanyl (2 mcg/mL).

Patient-controlled analgesia

Procedure

Each participant will receive a pump with oxycodone (1mg/ml) using a patient-controlled analgesia (PCA) technique, a bolus of 1 mL, and a lockout of 5 minutes for the first postoperative day.

Other names: PCA

Timed Up and Go test

Diagnostic Test

Investigators will measure the time the patient took to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while rotating 180 degrees. We will assess the patient before the surgery and 24 and 48 hours after hip replacement.

Other names: TUG

neuropathic pain symptom inventory

Diagnostic Test

The Neuropathic Pain Symptom Inventory (0-100; 0 denotes no pain, 100 the most severe pain) will be evaluated before the surgery and three and six months following the procedure.

Other names: NPSI

Lovett test

Diagnostic Test

A physiotherapist will use the six-grade Lovett scale to measure muscle strength, in which 0 denotes no muscle contractility, and 5 denotes the complete range of motion against gravity, with full resistance. We will test this before the surgery, 24 and 48 hours after the operation.

Visual analog scale

Diagnostic Test

Investigators will measure pain intensity with VAS (0-10; 0 denotes no pain, 10 maximal pain) before and after the surgery. Pain will be evaluated at rest and upon the activity.

Other names: VAS

Quality of Recovery 40

Diagnostic Test

Investigators will assess the quality of recovery with QoR-40 a day after the surgery, a month, and three months following the procedure. The minimal score is 40, and the maximal is 200. The higher the result, the better the quality of recovery is.

Other names: QoR-40

Ability to sit, stand upright, and walk

Diagnostic Test

A physiotherapist will evaluate the patient's ability to sit, stand upright, and walk at planned times.

Primary outcomes

  1. Opiod consumtion with PCA

    Time frame: From the admission to the postoperative care unit to the next postoperative day for 24 hours.

    Oxycodone consumtion used with a patient-controlled analgesia pump

Secondary outcomes

  1. Pain at rest

    Time frame: 24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation

    Pain measured at rest on the VAS (0-10)

  2. Pain upon activity

    Time frame: 24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation

    Pain measured upon activity on the VAS (0-10)

  3. Lovett test

    Time frame: 24 hours before the surgery, 24 and 48 hours after the operation

    The quadriceps femori's muscle strength on the Lovett scale (0-5)

  4. TUG

    Time frame: 24 hours before the surgery, 24 and 48 hours after the operation

    Timed Up and Go test in seconds

  5. QoR-40

    Time frame: It will be measured 24 hours, 30 days, and three months following the surgery.

    quality of recovery 40

  6. NPSI

    Time frame: 24 hours before the surgery and 3 and 6 months following the operation

    The Neuropathic Pain Symptom Inventory will be measured personally and after the discharge with a phone interview.

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

Comparison of Continuous Lumbar Erector Spinae Plane Block to Continuous Epidural Analgesia in Patients Undergoing Hip Replacement Surgery

Acronym: ESPB_HIP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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