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Clinical Trials/NCT04796363
NCT04796363
Completed
Not Applicable

Ultrasound Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation

Alexandria University1 site in 1 country60 target enrollmentNovember 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesia
Sponsor
Alexandria University
Enrollment
60
Locations
1
Primary Endpoint
Analgesic efficacy of ESPB
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Prospective interventional study

Detailed Description

The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery. The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB. The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery. Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.

Registry
clinicaltrials.gov
Start Date
November 25, 2020
End Date
January 21, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Mohamed Rabah Abdella

Principal investigator

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia

Exclusion Criteria

  • Patient refusal.
  • Allergy or contraindication to any of the studied medications or anaesthetic agents.
  • Chronic opioid analgesic use.
  • Morbid obesity (BMI ≥ 40 kg/m2).
  • Scoliosis or any vertebral anomalies or previous spinal surgeries.
  • Infection at the site of injection or any other contraindication for regional anaesthesia.
  • Duration of surgery more than 90 minutes.
  • Renal impairment.

Outcomes

Primary Outcomes

Analgesic efficacy of ESPB

Time Frame: Up to 24 postoperative hours

Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain

Secondary Outcomes

  • Spread of the injected dye in Erector Spinae plane(Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery.)
  • Dermatomal sensory coverage of ESPB(Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB.)

Study Sites (1)

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