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

January 19, 2021 updated by: Ezzat Ramzy Ezz, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: erector spinae arm
ultrasound guided erector spinae block
Procedure: erector spinae block
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.
Other Names:
  • erector spinae plane block
EXPERIMENTAL: thoracic paravertebral arm
ultrasound guided thoracic paravertebral block.
Procedure: thoracic paravertebral block
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.
ACTIVE_COMPARATOR: drug arm
pethidine (1 mg/kg ) once
Drug: Pethidine Only Product in Parenteral Dose Form
pethidine (1 mg/kg ) once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 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 Frame: 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
calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours
operation time
Time Frame: from start of anesthesia till the end of surgery , expected from 3-4 hours
Duration of the anesthesia and surgery to be documented
from start of anesthesia till the end of surgery , expected from 3-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

January 9, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (ACTUAL)

January 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pain control in nephrectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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