Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Erector Spinae Block for Acute Pain Management in Modified Radical Mastectomy
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
Peter Rafaat Edward Iskander
principal investigator
South Egypt Cancer Institute