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Clinical Trials/NCT05361837
NCT05361837RecruitingNot Applicable

Efficacy of Single Level Versus Bilevel Serratus Anterior Plane Block With Dexmedetomidine During Breast Cancer Surgery

National Cancer Institute, Egypt2 sites in 1 country172 target enrollmentStarted: May 10, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
172
Locations
2
Primary Endpoint
First time to receive analgesia

Study Overview

Brief Summary

This study aims to compare single level serratus block versus bilevel serratus block with and without dexmedetomidine in cancer patients undergoing modified radical mastectomy for breast cancer regarding pain control and possible side effects.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients scheduled for modified radical mastectomy,
  • Age 18-65 years,

Exclusion Criteria

  • patient refusal,
  • coagulation defects,
  • abnormal kidney or liver functions,
  • local infection at site of injection.

Arms & Interventions

Single level serratus anterior plane block with dexmedetomidine

Experimental

the allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics and dexmedetomidine

Intervention: Single level serratus anterior plane block with dexmedetomidine (Procedure)

Bilevel serratus anterior plane block

Experimental

the allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics only

Intervention: Bilevel serratus anterior plane block (Procedure)

Bilevel serratus anterior plane block with dexmedetomidine

Experimental

the allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics and dexmedetomidine

Intervention: Bilevel serratus anterior plane block with dexmedetomidine (Procedure)

Single level serratus anterior plane block

Active Comparator

the allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics only

Intervention: Single level serratus anterior plane block (Procedure)

Outcomes

Primary Outcomes

First time to receive analgesia

Time Frame: First 24 hours postoperatively

first time to receive morphine analgesia in hours

Total analgesic requisite

Time Frame: First 24 hours postoperatively

total amount of morphine consumption in the first 24 hours postoperatively in mg

Secondary Outcomes

  • Pain scores(First 24 hours postoperatively)
  • Side effects(First 24 hours postoperatively)
  • Perioperative heart rate values(First 24 hours)
  • Mean arterial blood pressure(First 24 hours)

Investigators

Sponsor
National Cancer Institute, Egypt
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Walaa Youssef Elsabeeny

Assistant professor of Anesthesia and Pain management

National Cancer Institute, Egypt

Study Sites (2)

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