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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03614091
• Other study ID #: AssiutU748918
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: April 2022

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: jehan ahmed sayed, MD
• Phone: +201006253939
• Email: jehan.alloul[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• ASA grade II-III.

• female patients in the age group of 18-50 yr.

• undergoing modi?ed 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 de?cits.

• psychiatric illness.

Related Conditions & MeSH terms

• Mastectomy
• Pain, Postoperative
• Pulmonary Atelectasis

Intervention

Procedure:
• Erector spinae plane block
20 ml Bupivacaine 0.5% below erector spinae muscle groups
• Paravertebral plane block
20 ml Bupivacaine 0.5% between pleura and costotransverse ligament

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	preoperative and 4 hours postoperative
Secondary	Opioid consumption	the total dose of nalbuphine in 24 hours	24 hours postoperatively
Secondary	Hospital stay	postoperative Hospital stay in hours	72 hours
Secondary	Dermatomal distribution	Dermatomal distribution of each block 30 minutes before the surgery (sensory loss tested by pin prick and Autonomic assessment by ethanol alcohol).	30 minutes after block will be assessed every 5 minutes
Secondary	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.	24 hours
Secondary	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.	24 hours postoperative