Paravertebral Block Versus Erector Spinae Plane Block for Modified Radical Mastectomy in Womens.
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Assiut, Egypt
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Paravertebral plane block group
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.
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20 ml Bupivacaine 0.5% between pleura and costotransverse ligament
Other Names:
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Active Comparator: Erector spinae plane block group
the transducer will be placed in a transverse orientation at T5 to T6 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 superficial to the transverse processes.
An 8cm 22-gauge block needle will be Inserted in-plane to the ultrasound beam in a cephalad-to-caudal 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.
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20 ml Bupivacaine 0.5% below erector spinae muscle groups
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pulmonary Function Tests(PFT)
Time Frame: preoperative and 24 hours postoperative
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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
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preoperative and 24 hours postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Opioid consumption
Time Frame: 24 hours postoperatively
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the total dose of nalbuphine in 24 hours
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24 hours postoperatively
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Hospital stay
Time Frame: 72 hours
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postoperative Hospital stay in hours
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72 hours
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Dermatomal distribution
Time Frame: 30 minutes after block will be assessed every 5 minutes
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Dermatomal distribution of each block 30 minutes before the surgery (sensory loss tested by pin prick and Autonomic assessment by ethanol alcohol).
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30 minutes after block will be assessed every 5 minutes
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Incidence of Side effects and complication during study
Time Frame: 24 hours
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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.
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24 hours
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Time to first analgesic requirement
Time Frame: 24 hours postoperative
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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.
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24 hours postoperative
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: jehan ahmed sayed, MD, Assisstant professor in Anaesthesia and ICU department,faculty of medicine,Assiut University ,egypt
- Study Chair: mahmoud abdel aziz ali, PHD, Professor of Anesthesia & ICU Faculty of Medicine - Assiut University,egypt
- Principal Investigator: mahmoud bahaa mousa, M.B.B.Ch, assisstant lecturer of Anaesthesia and ICU department,faculty of medicine ,Assiut University,egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AssiutU748918
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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