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NCT06300099 Clinical Trial

Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block

Breast Cancer Clinical Trial

Official title:
Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy A Randomized Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06300099
Other study ID # AZAST/Research/52/20-Jan-2024
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date April 1, 2024
Est. completion date October 1, 2024

Study information
Verified date March 2024
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results. The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy.

Description:

Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results. Serratus anterior plane block (SAPB) with ultrasound guidance is a fascial plane block that proved to be feasible, safe and effective tool for reduction of postoperative pain after thoracic and breast surgeries. In multiple instances, SAPB is used with additional adjuncts e.g. dexamethasone or dexmedetomidine to improve analgesic potency and duration.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 126
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: Consecutive American Society of Anesthesiologists (ASA) class I-II female patients with breast cancer indicated for modified radical mastectomy Exclusion Criteria: Allergy to the study medications . Patients will also be excluded if they have history of chronic pain conditions, opioid dependence or if they received prolonged analgesic therapy prior to surgery.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone
Dexamethasone as adjunct to serratus anterior plane block.
• Dexmedetomidine
Dexmedetomidine as adjunct to serratus anterior plane block.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative visual assessment scale for pain. Subjective pain assessment scale 72 hours postoperative
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