NCT06282666

Lumbar ESPB in Hip Replacement Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medical University of Lublin · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.
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.
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.
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.
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.
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.
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.
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.

Timeline

• Start date: 2024-02-19
• Primary completion: 2025-02-01
• Completion: 2025-08-01
• First posted: 2024-02-28
• Last updated: 2024-07-08

Locations

1 site across 1 country: Poland