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

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Procedure: erector spinae block; Procedure: thoracic paravertebral block; Drug: Pethidine Only Product in Parenteral Dose Form

• Registration Number: NCT04719507
• Lead Sponsor: Cairo University

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 .

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01
• Study First Submitted: 2021-01-09
• Study First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22
• Primary Completion: 2022-01
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
erector spinae arm	erector spinae block	ultrasound guided erector spinae block
thoracic paravertebral arm	thoracic paravertebral block	ultrasound guided thoracic paravertebral block.
drug arm	Pethidine Only Product in Parenteral Dose Form	pethidine (1 mg/kg ) once

Primary Outcome Measures

Name	Time	Method
Total morphine requirements 24 hours postoperatively	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 Outcome Measures

Name	Time	Method
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	Time span to the first postoperative analgesic request to be started from the time of the block till the first rescue dose of morphine
Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively	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)
operation time	from start of anesthesia till the end of surgery , expected from 3-4 hours	Duration of the anesthesia and surgery to be documented