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

NCT03614091 | Completed DMC

• 1 other identifier: AssiutU748918
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Pulmonary Atelectasis; Mastectomy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  preoperative and 24 hours postoperative

Secondary Outcomes (5)

• Opioid consumption

  24 hours postoperatively

• Hospital stay

  72 hours

• Dermatomal distribution

  30 minutes after block will be assessed every 5 minutes

• Incidence of Side effects and complication during study

  24 hours

• Time to first analgesic requirement

  24 hours postoperative

Study Arms (2)

Paravertebral plane block group

ACTIVE COMPARATOR

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

Erector spinae plane block group

ACTIVE COMPARATOR

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.

Procedure: Erector spinae plane block

Interventions

Erector spinae plane block PROCEDURE

20 ml Bupivacaine 0.5% below erector spinae muscle groups

Also known as: ultrasound guided Erector spinae plane block

Erector spinae plane block group

Paravertebral plane block PROCEDURE

20 ml Bupivacaine 0.5% between pleura and costotransverse ligament

Also known as: ultrasound guided thoracic Paravertebral plane block

Paravertebral plane block group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (1)

• Sayed JA, Hamed R, Abdelraouf AM, El-Hagagy NYM, El Dean Mousa MB, Abdel-Wahab AH. A comparative study of respiratory effects of erector spinae plane block versus paravertebral plane block for women undergoing modified radical mastectomy. BMC Anesthesiol. 2024 Jul 30;24(1):262. doi: 10.1186/s12871-024-02632-4.

  PMID: 39080545 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• jehan ahmed sayed, MD

  Assisstant professor in Anaesthesia and ICU department,faculty of medicine,Assiut University ,egypt

  STUDY DIRECTOR

• mahmoud abdel aziz ali, PHD

  Professor of Anesthesia & ICU Faculty of Medicine - Assiut University,egypt

  STUDY CHAIR

• mahmoud bahaa mousa, M.B.B.Ch

  assisstant lecturer of Anaesthesia and ICU department,faculty of medicine ,Assiut University,egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double Blind (caregiver,outcome Assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 3, 2018
• Study Start: February 1, 2020
• Primary Completion: April 5, 2023
• Study Completion: December 27, 2023
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)