Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy

Study Overview
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Brief Summary
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the study aims to compare the analgesic efficacy of erector spinae plane block versus thoracic paravertebral block after open nephrectomy surgery.

Detailed Description
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Open nephrectomy is associated with substantial postoperative pain, pain relief in patients undergoing this procedure is usually provided either by thoracic epidural analgesia (EA) or systemic analgesics. EA is a very useful option for the management of postoperative pain in patients undergoing abdominal surgeries, but the risks and contraindications linked to EA like hypotension ,headache ,nerve damage or infection may limit its use. Systemic analgesics in the form of opioid analgesics may give rise to side effects like nausea ,vomiting ,constipation, allergy or drowsiness and often provide insufficient analgesia. Hence, other methods of postoperative pain management are desired. Sensory level target according to the incision site Flank(T9-T11) , Thoraco-abdominal (T7-T12 ) and Trans-abdominal (T6-T10). Ultrasound (US) guided erector spinae plane (ESP) block is one of the interfascial plane blocks that target the dorsal and ventral rami of the spinal nerves. Although there is no sufficient evidence for the spread of local anesthetic to the ventral rami, recent anecdotal reports demonstrated effective postoperative analgesia after thoracic and lumbar surgeries affecting both the ventral and dorsal rami .According to a previous study, Erector Spinae Plane block has allowed a reduction in opioid consumption and excellent pain control in partial nephrectomy. Paravertebral block (PVB) is a technique where a local anesthetic is deposited into a space found on both sides of the spine, called the paravertebral space. It is a block with a dermatomal distribution of pain relief depending on the level of the spine at which the block is sited and the quantity and type of deposited local anesthetic. PVB is effective for pain relief in the thoracic, abdominal and limb regions .

Official Title
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Ultrasound Guided Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy : A Randomized Controlled Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Procedure: erector spinae block
* Procedure: thoracic paravertebral block
* Drug: Pethidine Only Product in Parenteral Dose Form


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (30-60 years) . Patients with ASA I , II score Exclusion Criteria: Patient's refusal Coagulopathy to be cancelled if ( INR>1.4 , Platelets count <100x109 ) Infection at the injection site. Allergy to local anesthetics. Patients receiving opioids for chronic analgesic therapy

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erector spinae arm<br>ultrasound guided erector spinae block | Procedure: erector spinae block<br>* ultrasound probe is placed parallel to the vertebral spine at T4 level and shifted 3 cm laterally to obtain the appropriate visualization. Under aseptic precautions, the needle is inserted and advanced perpendicular to the skin in all planes to contact the transverse process of the vertebra at a variable depth of 2-4 cm from the skin depending on the build of the individual. At this point, the needle tip lies between the erector spinae muscle and transverse process. After negative aspiration, 20 ml of 0.25% bupivacaine is administered in cephalad and caudal directions.<br>* Other names: erector spinae plane block;|
| Experimental: thoracic paravertebral arm<br>ultrasound guided thoracic paravertebral block. | Procedure: thoracic paravertebral block<br>* ultrasound probe is placed parallel to the vertebral spine at T4 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of pleura, transverse process and paravertebral space, the needle is inserted cranial to caudal direction using in-plane approach . After confirming the displacement of pleura with 0.5-1 ml of local anesthetic (LA), 20 ml of 0.25% bupivacaine is administered for the block.<br>|
| Active Comparator: drug arm<br>pethidine (1 mg/kg ) once | Drug: Pethidine Only Product in Parenteral Dose Form<br>* pethidine (1 mg/kg ) once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine requirements 24 hours postoperatively | morphine increment ( 0.02 mg/kg IV ) will be added to maintain a resting visual analogue score at <3 and the total 24-hours morphine consumption will be recorded | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively | the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity .no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) | 2, 4, 6, 12, 18, and 24 hours postoperatively | 
| Time span to the first postoperative analgesia | Time span to the first postoperative analgesic request to be started from the time of the block till the first rescue dose of morphine | calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours | 
| operation time | Duration of the anesthesia and surgery to be documented | from start of anesthesia till the end of surgery , expected from 3-4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open nephrectomy