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Clinical Trials/NCT04719507
NCT04719507
Unknown
Not Applicable

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

Cairo University0 sites45 target enrollmentJanuary 2021

Overview

Phase
Not Applicable
Intervention
erector spinae block
Conditions
Pain, Postoperative
Sponsor
Cairo University
Enrollment
45
Primary Endpoint
Total morphine requirements 24 hours postoperatively
Last Updated
5 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
January 2021
End Date
March 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ezzat Ramzy Ezz

principle investigator

Cairo University

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

Arms & Interventions

erector spinae arm

ultrasound guided erector spinae block

Intervention: erector spinae block

thoracic paravertebral arm

ultrasound guided thoracic paravertebral block.

Intervention: thoracic paravertebral block

drug arm

pethidine (1 mg/kg ) once

Intervention: Pethidine Only Product in Parenteral Dose Form

Outcomes

Primary Outcomes

Total morphine requirements 24 hours postoperatively

Time Frame: 24 hours postoperative

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

Secondary Outcomes

  • Time span to the first postoperative analgesia(calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours)
  • Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively(2, 4, 6, 12, 18, and 24 hours postoperatively)
  • operation time(from start of anesthesia till the end of surgery , expected from 3-4 hours)

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