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

• ClinicalTrials.gov Identifier: NCT03614091
• Recruitment Status: Recruiting
• First Posted: August 3, 2018
• Last Update Posted: May 19, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): jehan ahmed sayed, Assiut University

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.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative; Pulmonary Atelectasis; Mastectomy	Procedure: Erector spinae plane block; Procedure: Paravertebral plane block	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Masking Description: Double Blind (caregiver,outcome Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: February 1, 2020
• Estimated Primary Completion Date: April 2021
• Estimated Study Completion Date: April 2022

Arms and Interventions

Arm	Intervention/treatment
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.	Procedure: Paravertebral plane block; 20 ml Bupivacaine 0.5% between pleura and costotransverse ligament; Other Name: ultrasound guided thoracic Paravertebral plane block
Active Comparator: Erector spinae plane block group; 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.	Procedure: Erector spinae plane block; 20 ml Bupivacaine 0.5% below erector spinae muscle groups; Other Name: ultrasound guided Erector spinae plane block

Outcome Measures

Primary Outcome Measures :

1. Pulmonary Function Tests(PFT) [ Time Frame: preoperative and 24 hours postoperative ]
   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
2. Arterial blood gases [ Time Frame: preoperative and 4 hours postoperative ]
   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 :

1. Opioid consumption [ Time Frame: 24 hours postoperatively ]
   the total dose of nalbuphine in 24 hours
2. Hospital stay [ Time Frame: 72 hours ]
   postoperative Hospital stay in hours
3. Dermatomal distribution [ Time Frame: 30 minutes after block will be assessed every 5 minutes ]
   Dermatomal distribution of each block 30 minutes before the surgery (sensory loss tested by pin prick and Autonomic assessment by ethanol alcohol).
4. Incidence of Side effects and complication during study [ Time Frame: 24 hours ]
   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.
5. Time to first analgesic requirement [ Time Frame: 24 hours postoperative ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: 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
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: jehan ahmed sayed, MD; +201006253939; jehan.alloul@yahoo.com

Contact: mahmoud bahaa mousa, M.B.B.Ch, M.Sc; +201009465426; dr.mahmoudbahaa@aun.edu.eg

Locations

Egypt

Assiut University; Recruiting

Assiut, Egypt

Sponsors and Collaborators

Assiut University

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

More Information

• Responsible Party: jehan ahmed sayed, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03614091
• Other Study ID Numbers: AssiutU748918
• First Posted: August 3, 2018
• Last Update Posted: May 19, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by jehan ahmed sayed, Assiut University:

Paravertebral block; Erector spinae plane block; Modified radical mastectomy; respirometer

Additional relevant MeSH terms:

Pulmonary Atelectasis; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Lung Diseases; Respiratory Tract Diseases