Lumbar ESPB in Hip Replacement Surgery (ESPB_HIP)

Medical University of Lublin

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06282666

KE-0254/150/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Epidural

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Ability to sit, stand upright, and walk

Diagnostic Test: Quality of Recovery 40

Diagnostic Test: Timed Up and Go test

Procedure: Epidural analgesia

Diagnostic Test: Visual analog scale

Diagnostic Test: Lovett test

Procedure: Spinal anesthesia

Diagnostic Test: neuropathic pain symptom inventory

Procedure: patient-controlled analgesia

ESPB

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Ability to sit, stand upright, and walk

Diagnostic Test: Quality of Recovery 40

Diagnostic Test: Timed Up and Go test

Diagnostic Test: Visual analog scale

Diagnostic Test: Lovett test

Procedure: Spinal anesthesia

Diagnostic Test: neuropathic pain symptom inventory

Procedure: lumbar erector spinae plane block

Procedure: patient-controlled analgesia