Clinical trial NCT04719507: Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy
Official title: Ultrasound Guided Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Keywords: open nephrectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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 .

Eligibility criteria: 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

Primary outcomes:
measure: Total morphine requirements 24 hours postoperatively
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively
timeFrame: 2, 4, 6, 12, 18, and 24 hours postoperatively
measure: Time span to the first postoperative analgesia
timeFrame: calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours
measure: operation time
timeFrame: from start of anesthesia till the end of surgery , expected from 3-4 hours
Other outcomes:
Locations:
Study officials:
References:
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