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Paravertebral Block Versus Erector Spinae Plane Block for Modified Radical Mastectomy in Womens.

Primary Purpose

Pain, Postoperative, Pulmonary Atelectasis, Mastectomy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector spinae plane block
Paravertebral plane block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Paravertebral block, Erector spinae plane block, Modified radical mastectomy, respirometer

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA grade II-III.
  • female patients in the age group of 18-50 yr.
  • undergoing modified radical mastectomy under general anesthesia.
  • BMI <40 kg.m2.

Exclusion Criteria:

  • pre-existing infection at the block site.
  • Coagulopathy.
  • morbid obesity (BMI >40 kg m-2).
  • allergy to local anesthetics.
  • decreased pulmonary reserve.
  • major cardiac disorders.
  • renal dysfunction.
  • pre-existing neurological deficits.
  • psychiatric illness.

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Paravertebral plane block group

Erector spinae plane block group

Arm Description

The TPVB will be administered at the T4 level with the patient in the sitting position.The ultrasound probe will be placed 5 cm from the midline in the craniocaudal direction and moved medially to identify the transverse process and parietal pleura. The superior costotransverse ligament was identified as a collection of homogeneous linear echogenic bands alternating with echo-poor areas running from one transverse process to the next. Bubivacaine0.5%, 20 ml will be deposited in the space between the pleura and the costotransverse ligament.

the transducer will be placed in a transverse orientation to identify the spinous process, lamina,and transverse process.The tip of the transverse process will be centered on the ultrasound screen, and the transducer will be rotated 90 degrees into a longitudinal orientation to obtain a parasagittal view. Depending on the level imaged, 2 or 3 hypoechoic muscle layers were identified overlying the tip of the transverse processes. From T1 to T5 the erector spinae, rhomboid major and trapezius muscles are visible posterior and superfacial to the transverse processes. An 8cm 22-gauge block needle will be Inserted in-plane to the ultrasound beam in a cephalad-to-caudad Direction to place the needle tip between the posterior fascia of Erector spinae and the tip of the targeted transverse process.following which a total of 20 mL of 0.5%bupivacaine will be injected.

Outcomes

Primary Outcome Measures

Pulmonary Function Tests(PFT)
Pulmonary function test (PFTs) will be performed for all of them in the day before operation .pulmonary function tests will assess via a portable spirometer (Enraf-Nonius, Model SPIRO 601 Medical Technologies) with the patient in the sitting or semi-recumbent position. PFTs will obtain with the elimination of outliers from data analysis
Arterial blood gases
The three component PH, PaO2, PaCO2 will be observed and recorded for both preoperative before the block and postoperative by 4 hours both will be obtained at room air

Secondary Outcome Measures

Opioid consumption
the total dose of nalbuphine in 24 hours
Hospital stay
postoperative Hospital stay in hours
Dermatomal distribution
Dermatomal distribution of each block 30 minutes before the surgery (sensory loss tested by pin prick and Autonomic assessment by ethanol alcohol).
Incidence of Side effects and complication during study
Any side effects or complication will be observed and managed in the first 24 hours postoperative Hours will be recorded: nausea, vomiting, lower limb weakness, Respiratory depression (Decrease in SPo2 of less than 90% Requiring supplementary oxygen), urinary retention, rash and Pruritus will be noted and managed.
Time to first analgesic requirement
the time from end of surgery to the first requirement of Postoperative analgesia by measuring verbal numeric rating scale, which will be assessed in 0-0.5-1-2-4-6-8-12-24 hours,Patients will be administered 6mg nalbuphine as rescue analgesia whenever the pain score (VNRS) reached 4 or more.

Full Information

First Posted
July 13, 2018
Last Updated
May 17, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03614091
Brief Title
Paravertebral Block Versus Erector Spinae Plane Block for Modified Radical Mastectomy in Womens.
Official Title
Analgesic and Pulmonary Function Effects of Erector Spinae Plane Block Versus Paravertebral Plane Block for Women's Undergoing Modified Radical Mastectomy; Randomized Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
postoperative pain following Modified radical mastectomy is severe specially after dissection of tissues .paravertebral plane block provides an excellent postoperative analgesia for women's,but it carry the risk of pneumothorax which it reported in some cases.Erector spinae plane block is a recent block has been mentioned in many case reports as a safe,quick and can be used in outpatient setting. we use a comparative study to compare the postoperative analgesia between both blocks and the affection of postoperative pain following both blocks if any on pulmonary functions.
Detailed Description
Postoperative pain is one of the commonest problems encountered by anesthesiologists in their practice, especially after radical mastectomy surgeries , in which post-operative pain would cause a restrictive respiratory dysfunction, which is associated with poor postoperative outcomes. Postoperative pulmonary complications (PPCs) are the leading cause of death and increase hospital care expenditures in cardiothoracic and non- cardiothoracic surgery. Included under the heading of (PPCs) are respiratory failure, pneumonia, atelectasis, and exacerbation of chronic obstructive pulmonary disease. Modified radical mastectomy, usually performed for the treatment of breast cancer, is associated with considerable acute postoperative pain and restricted shoulder mobility An estimated 40% of women report significant pain symptoms following mastectomy Poor pain relief has been associated with additional healthcare costs, resource utilization and prolonged inpatient stay after surgery. the thoracic paravertebral block (TPVB) is the most widely used technique to provide postoperative analgesia after breast surgeries Advantages of a TPVB technique include reduced postoperative pain, analgesic consumption and shorter post anesthesia care unit (PACU) stay There is also evidence to suggest that TPVB may have a favorable impact on cancer recurrence after mastectomy. Paravertebral blockade results in somatosensory and sympathetic blockade after injection of local anesthetic solution to the paravertebral space posterior to the pleura. Erector spinae plane (ESP) block is a recently described technique which may be an alternative to PVB for providing thoracic analgesia. Numerous case reports and case series describe ESP block for the management of acute and chronic thoracic pain. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. Radiological imaging in a cadaver model has demonstrated that a single injection at the level of the T5 transverse process produced cranio-caudal spread between C7 and T8 . This accounts for the extensive sensory block that has been observed in case reports and is at least as extensive as the spread seen with TPVB ESP is a more superficial block with a better defined end-point - injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. Furthermore, ESP does not have the same risk of pneumothorax as TPVB. There have been no randomized controlled trials involving ESP to date. All descriptions of the technique have been in case report / series format. The investigators hypothesize that ESP block efficacy is not inferior to TPVB with reference to dermatomal sensory spread and analgesic efficacy, while being easier to perform, has less associated discomfort and fewer complication risk ESP has been no randomized in many case trials and they found that it effective as postoperative analgesia in modified radical mastectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pulmonary Atelectasis, Mastectomy
Keywords
Paravertebral block, Erector spinae plane block, Modified radical mastectomy, respirometer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Double Blind (caregiver,outcome Assessor)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paravertebral plane block group
Arm Type
Active Comparator
Arm Description
The TPVB will be administered at the T4 level with the patient in the sitting position.The ultrasound probe will be placed 5 cm from the midline in the craniocaudal direction and moved medially to identify the transverse process and parietal pleura. The superior costotransverse ligament was identified as a collection of homogeneous linear echogenic bands alternating with echo-poor areas running from one transverse process to the next. Bubivacaine0.5%, 20 ml will be deposited in the space between the pleura and the costotransverse ligament.
Arm Title
Erector spinae plane block group
Arm Type
Active Comparator
Arm Description
the transducer will be placed in a transverse orientation to identify the spinous process, lamina,and transverse process.The tip of the transverse process will be centered on the ultrasound screen, and the transducer will be rotated 90 degrees into a longitudinal orientation to obtain a parasagittal view. Depending on the level imaged, 2 or 3 hypoechoic muscle layers were identified overlying the tip of the transverse processes. From T1 to T5 the erector spinae, rhomboid major and trapezius muscles are visible posterior and superfacial to the transverse processes. An 8cm 22-gauge block needle will be Inserted in-plane to the ultrasound beam in a cephalad-to-caudad Direction to place the needle tip between the posterior fascia of Erector spinae and the tip of the targeted transverse process.following which a total of 20 mL of 0.5%bupivacaine will be injected.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Other Intervention Name(s)
ultrasound guided Erector spinae plane block
Intervention Description
20 ml Bupivacaine 0.5% below erector spinae muscle groups
Intervention Type
Procedure
Intervention Name(s)
Paravertebral plane block
Other Intervention Name(s)
ultrasound guided thoracic Paravertebral plane block
Intervention Description
20 ml Bupivacaine 0.5% between pleura and costotransverse ligament
Primary Outcome Measure Information:
Title
Pulmonary Function Tests(PFT)
Description
Pulmonary function test (PFTs) will be performed for all of them in the day before operation .pulmonary function tests will assess via a portable spirometer (Enraf-Nonius, Model SPIRO 601 Medical Technologies) with the patient in the sitting or semi-recumbent position. PFTs will obtain with the elimination of outliers from data analysis
Time Frame
preoperative and 24 hours postoperative
Title
Arterial blood gases
Description
The three component PH, PaO2, PaCO2 will be observed and recorded for both preoperative before the block and postoperative by 4 hours both will be obtained at room air
Time Frame
preoperative and 4 hours postoperative
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
the total dose of nalbuphine in 24 hours
Time Frame
24 hours postoperatively
Title
Hospital stay
Description
postoperative Hospital stay in hours
Time Frame
72 hours
Title
Dermatomal distribution
Description
Dermatomal distribution of each block 30 minutes before the surgery (sensory loss tested by pin prick and Autonomic assessment by ethanol alcohol).
Time Frame
30 minutes after block will be assessed every 5 minutes
Title
Incidence of Side effects and complication during study
Description
Any side effects or complication will be observed and managed in the first 24 hours postoperative Hours will be recorded: nausea, vomiting, lower limb weakness, Respiratory depression (Decrease in SPo2 of less than 90% Requiring supplementary oxygen), urinary retention, rash and Pruritus will be noted and managed.
Time Frame
24 hours
Title
Time to first analgesic requirement
Description
the time from end of surgery to the first requirement of Postoperative analgesia by measuring verbal numeric rating scale, which will be assessed in 0-0.5-1-2-4-6-8-12-24 hours,Patients will be administered 6mg nalbuphine as rescue analgesia whenever the pain score (VNRS) reached 4 or more.
Time Frame
24 hours postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
After providing written informed consent, 40 patients, (American Society of Anesthesia):ASA grade II-III, female patients in the age group of 18-50 yr, who will be undergoing modified radical mastectomy under general anesthesia will be included
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA grade II-III. female patients in the age group of 18-50 yr. undergoing modified radical mastectomy under general anesthesia. BMI <40 kg.m2. Exclusion Criteria: pre-existing infection at the block site. Coagulopathy. morbid obesity (BMI >40 kg m-2). allergy to local anesthetics. decreased pulmonary reserve. major cardiac disorders. renal dysfunction. pre-existing neurological deficits. psychiatric illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jehan ahmed sayed, MD
Phone
+201006253939
Email
jehan.alloul@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
mahmoud bahaa mousa, M.B.B.Ch, M.Sc
Phone
+201009465426
Email
dr.mahmoudbahaa@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jehan ahmed sayed, MD
Organizational Affiliation
Assisstant professor in Anaesthesia and ICU department,faculty of medicine,Assiut University ,egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mahmoud abdel aziz ali, PHD
Organizational Affiliation
Professor of Anesthesia & ICU Faculty of Medicine - Assiut University,egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
mahmoud bahaa mousa, M.B.B.Ch
Organizational Affiliation
assisstant lecturer of Anaesthesia and ICU department,faculty of medicine ,Assiut University,egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Paravertebral Block Versus Erector Spinae Plane Block for Modified Radical Mastectomy in Womens.

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