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

NCT ID: NCT03614091

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2023-12-27

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.

Conditions

Pain, Postoperative; Pulmonary Atelectasis; Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Paravertebral plane block

Intervention Type: PROCEDURE

20 ml Bupivacaine 0.5% between pleura and costotransverse ligament

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.

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type: PROCEDURE

20 ml Bupivacaine 0.5% below erector spinae muscle groups

Interventions

Erector spinae plane block

20 ml Bupivacaine 0.5% below erector spinae muscle groups

Intervention Type: PROCEDURE

Paravertebral plane block

20 ml Bupivacaine 0.5% between pleura and costotransverse ligament

Intervention Type: PROCEDURE

Other Intervention Names

ultrasound guided Erector spinae plane block; ultrasound guided thoracic Paravertebral plane block

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

jehan ahmed sayed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

jehan ahmed sayed, MD

Role: STUDY_DIRECTOR

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

mahmoud abdel aziz ali, PHD

Role: STUDY_CHAIR

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

mahmoud bahaa mousa, M.B.B.Ch

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 39080545 (View on PubMed)

Other Identifiers

AssiutU748918

Identifier Type: -

Identifier Source: org_study_id