Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
erector spinae block
thoracic paravertebral block
Pethidine Only Product in Parenteral Dose Form
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring open nephrectomy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
erector spinae arm
thoracic paravertebral arm
drug arm
Arm Description
ultrasound guided erector spinae block
ultrasound guided thoracic paravertebral block.
pethidine (1 mg/kg ) once
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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
operation time
Duration of the anesthesia and surgery to be documented
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04719507
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
open nephrectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
erector spinae arm
Arm Type
Experimental
Arm Description
ultrasound guided erector spinae block
Arm Title
thoracic paravertebral arm
Arm Type
Experimental
Arm Description
ultrasound guided thoracic paravertebral block.
Arm Title
drug arm
Arm Type
Active Comparator
Arm Description
pethidine (1 mg/kg ) once
Intervention Type
Procedure
Intervention Name(s)
erector spinae block
Other Intervention Name(s)
erector spinae plane block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
thoracic paravertebral block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pethidine Only Product in Parenteral Dose Form
Intervention Description
pethidine (1 mg/kg ) once
Primary Outcome Measure Information:
Title
Total morphine requirements 24 hours postoperatively
Description
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
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively
Description
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)
Time Frame
2, 4, 6, 12, 18, and 24 hours postoperatively
Title
Time span to the first postoperative analgesia
Description
Time span to the first postoperative analgesic request to be started from the time of the block till the first rescue dose of morphine
Time Frame
calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours
Title
operation time
Description
Duration of the anesthesia and surgery to be documented
Time Frame
from start of anesthesia till the end of surgery , expected from 3-4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ezzat ezz
Phone
01284994135
Email
ezzatramzy627@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karim ghaleb
Phone
01007451161
Email
karim.ghaleb87@gmail.com
12. IPD Sharing Statement
Citations:
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28663622
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Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy
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