Lumbar ESPB in Hip Replacement Surgery (ESPB_HIP)

Comparison of Continuous Lumbar Erector Spinae Plane Block to Continuous Epidural Analgesia in Patients Undergoing 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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain, Postoperative; Analgesia; Pain, Acute; Anesthesia; Pain, Chronic; Postoperative Pain, Chronic; Coxarthrosis; Spinal
• Intervention / Treatment: 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; Procedure: lumbar erector spinae plane block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lublin, Poland, 20-081
    • II Department of Anesthesia and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epidural; 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; 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; Procedure: Epidural analgesia; 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).; Procedure: patient-controlled analgesia; 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; Diagnostic test: Timed Up and Go 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; Diagnostic test: neuropathic pain symptom inventory; 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; Diagnostic test: Lovett 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.; Diagnostic test: Visual analog scale; 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; Diagnostic test: Quality of Recovery 40; 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; Diagnostic test: Ability to sit, stand upright, and walk; A physiotherapist will evaluate the patient's ability to sit, stand upright, and walk at planned times.
Experimental: ESPB; 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; 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; Procedure: patient-controlled analgesia; 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; Diagnostic test: Timed Up and Go 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; Diagnostic test: neuropathic pain symptom inventory; 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; Diagnostic test: Lovett 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.; Diagnostic test: Visual analog scale; 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; Diagnostic test: Quality of Recovery 40; 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; Diagnostic test: Ability to sit, stand upright, and walk; A physiotherapist will evaluate the patient's ability to sit, stand upright, and walk at planned times.; Procedure: lumbar erector spinae plane block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at rest	Pain measured at rest on the VAS (0-10)	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	Pain measured upon activity on the VAS (0-10)	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	The quadriceps femori's muscle strength on the Lovett scale (0-5)	24 hours before the surgery, 24 and 48 hours after the operation
TUG	Timed Up and Go test in seconds	24 hours before the surgery, 24 and 48 hours after the operation
QoR-40	quality of recovery 40	It will be measured 24 hours, 30 days, and three months following the surgery.
NPSI	The Neuropathic Pain Symptom Inventory will be measured personally and after the discharge with a phone interview.	24 hours before the surgery and 3 and 6 months following the operation

Collaborators and Investigators

• Sponsor: Medical University of Lublin
• Investigators: Study Chair: Paweł Piwowarczyk, M.D., Ph.D., Medical University of Lublin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: quality of recovery; spinal anesthesia; epidural analgesia; patient-controlled analgesia; visual analog scale; erector spinae plane block; Timed Up and Go test; neuropathic pain symptom inventory; Lovett scale
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Neurobehavioral Manifestations; Osteoarthritis; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Chronic Pain; Acute Pain; Agnosia; Osteoarthritis, Hip; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Anesthesia and Analgesia; Immunologic Techniques; Exercise; Anesthesia, Conduction; Anesthesia; Analgesia; Locomotion; Immunologic Tests; Skin Tests; Immune System Phenomena; Posture; Antigen-Antibody Reactions; Anesthesia, Spinal; Walking; Passive Cutaneous Anaphylaxis; Analgesia, Epidural; Sitting Position; Analgesia, Patient-Controlled; Visual Analog Scale
• Other Study ID Numbers: KE-0254/150/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No