Lumbar ESPB in Hip Replacement Surgery

NCT06282666 | Recruiting DMC

• 1 other identifier: KE-0254/150/2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coxarthrosis; Pain, Postoperative; Pain, Acute; Pain, Chronic; Postoperative Pain, Chronic; Analgesia; Quality of Life; Anesthesia; Spinal

Keywords

erector spinae plane block; epidural analgesia; quality of recovery; patient-controlled analgesia; Timed Up and Go test; visual analog scale; neuropathic pain symptom inventory; Lovett scale; spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Opiod consumtion with PCA

  Oxycodone consumtion used with a patient-controlled analgesia pump

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

Secondary Outcomes (6)

• Pain at rest

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

• Pain upon activity

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

• Lovett test

  24 hours before the surgery, 24 and 48 hours after the operation

• TUG

  24 hours before the surgery, 24 and 48 hours after the operation

• QoR-40

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

Study Arms (2)

Epidural

EXPERIMENTAL

Combined spinal and epidural anesthesia will be performed before the surgery in the patient's lateral position with the operated hip down. The Espocan set will be used (B.Braun). After identification of the epidural space on the level of L3/L4, 0.5% bupivacaine (Marcaine Heavy Spinal) with fentanyl (5 mcg/mL) will be injected through the 27 G pencil point spinal needle. Then, the epidural catheter will be placed and a test dose of 2% lidocaine (2 mL) will be administered. At the end of the surgery, the patient will receive 5 mL of a mixture containing 0.1% bupivacaine with fentanyl (2 mcg/mL). Moreover, we will administer 5 mg of oxycodone i.v. the mixture of bupivacaine and fentanyl will be administered in a constant flow of 5 mL/h for a day.

Procedure: Spinal anesthesia; Procedure: Epidural analgesia; Procedure: patient-controlled analgesia; Diagnostic Test: Timed Up and Go test; Diagnostic Test: neuropathic pain symptom inventory; Diagnostic Test: Lovett test; Diagnostic Test: Visual analog scale; Diagnostic Test: Quality of Recovery 40; Diagnostic Test: Ability to sit, stand upright, and walk

ESPB

EXPERIMENTAL

Spinal anesthesia will be performed in the patient's lateral position with the operated hip down. 0.5% bupivacaine (Marcaine Heavy Spinal) with fentanyl (5 mcg/mL) will be used and a 25-27 G pencil point spinal needle. The lumbar ESPB will be performed under ultrasound control at the L3 level on the ipsilateral site of the surgery. After dissection with 0.9 NaCl, a catheter will be left in the ESP. Then, we will administer 0.25% bupivacaine with epinephrine (5mcg/mL), 0.4 mL per kg, up to 40 mL. Moreover, 5 mg of oxycodone i.v. will be administered A mixture of 0.1% bupivacaine with fentanyl (2 mcg/mL) will be given in a constant flow of 5 mL/h for a day.

Procedure: Spinal anesthesia; Procedure: lumbar erector spinae plane block; Procedure: patient-controlled analgesia; Diagnostic Test: Timed Up and Go test; Diagnostic Test: neuropathic pain symptom inventory; Diagnostic Test: Lovett test; Diagnostic Test: Visual analog scale; Diagnostic Test: Quality of Recovery 40; Diagnostic Test: Ability to sit, stand upright, and walk

Interventions

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.

Also known as: Subarachnoid anesthesia

ESPB; Epidural

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.

Also known as: ESPB

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).

Epidural

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.

Also known as: PCA

ESPB; Epidural

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.

Also known as: TUG

ESPB; Epidural

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.

Also known as: NPSI

ESPB; Epidural

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.

ESPB; Epidural

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.

Also known as: VAS

ESPB; Epidural

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.

Also known as: QoR-40

ESPB; Epidural

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.

ESPB; Epidural

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

II Department of Anesthesia and Intensive Care

Lublin, 20-081, Poland

RECRUITING

Related Publications (1)

• Hanych A, Kutnik P, Pasiak P, Zakrzewska-Szalak A, Wichowska O, Jednakiewicz M, Nogalski A, Piwowarczyk P, Borys M. Continuous lumbar erector spinae plane block as an alternative to epidural analgesia in pain treatment in patients undergoing hip replacement surgery - a prospective pilot study. Anaesthesiol Intensive Ther. 2023;55(4):272-276. doi: 10.5114/ait.2023.132517.

  PMID: 38084571 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Pain, Postoperative; Acute Pain; Chronic Pain; Agnosia

Interventions

Anesthesia, Spinal; Analgesia, Epidural; Analgesia, Patient-Controlled; Passive Cutaneous Anaphylaxis; Visual Analog Scale; Sitting Position; Walking

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Analgesia; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Locomotion; Movement; Exercise; Motor Activity

Study Officials

• Paweł Piwowarczyk, M.D., Ph.D.

  Medical University of Lublin

  STUDY CHAIR

Central Study Contacts

Michał Borys, M.D., Ph.D.

CONTACT

506350569; michalborys1@gmail.com

Paweł Kutnik, M.D.

CONTACT

608769410; pe.kutnik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will not be aware of the type of continuous blockade. Care providers, including doctors and nurses, will not be aware of patient allocation. Physiotherapists assessing outcomes will not be aware of patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Two groups will be randomly allocated to Epidural and ESPB (1:1)

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 28, 2024
• Study Start: February 19, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)