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Clinical Trials/NCT04732390
NCT04732390UnknownPhase 2

Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Erector Spinae Block for Acute Pain Management in Modified Radical Mastectomy

South Egypt Cancer Institute2 sites in 1 country40 target enrollmentStarted: December 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
analgesia request

Study Overview

Brief Summary

To evaluate the analgesic efficacy of magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute pain management

Detailed Description

The participating female will be randomly allocated using computer generated randomization program (http://www.randoiler.org) into one of 2 groups.

Group (C) / (I):20 patients (control group):

Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.

Group (M) / (III): 20 patients (magnesium slphate group):

Patient will receive 20ml 0.25% levobupivacaine above + 0.7 mg/kg MgSo4. The patient, the anesthesiologist who administered the drugs and the data collector will be blinded to the study drugs.

Study Design

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

Eligibility Criteria

Ages
25 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • female patient
  • American society of anesthesiologists (ASA) I and II physical status
  • age from 25 to 70 years old
  • scheduled for either left or right modified radical mastectomy (MRM)

Exclusion Criteria

  • infection of the skin at or near site of needle puncture
  • coagulopathy,
  • drug hypersensitivity or allergy to the studied drugs,
  • central or peripheral neuropathy,
  • significant organ dysfunction cardiac dysrrhythmias,
  • obesity (BMI>35kg/m2)
  • recently use analgesic drugs

Outcomes

Primary Outcomes

analgesia request

Time Frame: 24 hours

first request for analgesia .

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
South Egypt Cancer Institute
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Peter Rafaat Edward Iskander

principal investigator

South Egypt Cancer Institute

Study Sites (2)

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