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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paweł Piwowarczyk, M.D., Ph.D. | Medical University of Lublin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| II Department of Anesthesia and Intensive Care | Lublin | 20-081 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38084571 | Background | 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. |
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Two groups will be randomly allocated to Epidural and ESPB (1:1)
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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.
|
| 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. |
|
|
| 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. |
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| 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. |
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|
| 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. |
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| 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. |
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| 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. |
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| 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. |
|
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 |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D015360 | Analgesia, Epidural |
| D016058 | Analgesia, Patient-Controlled |
| D010323 | Passive Cutaneous Anaphylaxis |
| D064232 | Visual Analog Scale |
| D000077708 | Sitting Position |
| D016138 | Walking |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000698 | Analgesia |
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D008124 | Locomotion |
| D009068 | Movement |
| D015444 | Exercise |
| D009043 | Motor Activity |
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