Skip to content

Analgesic Efficacy of Ultrasound Guided Erector Spinae Block for Modified Radical Mastectomy

Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levo-bupivacine in Ultrasound Guided Erector Spinae Plan Block for Modified Radical Mastectomy

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04732364
Enrollment
60
Registered
2021-02-01
Start date
2018-04-30
Completion date
2021-02-28
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Erector Spinae Block, magnesium sulphate, dexmedetomidine

Brief summary

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

Detailed description

3 groups. Group (C) / (I):20 patient (control group) : Patients will receive 20 ml 0.25% levobupivacaine into the interfascial plane below erector spinae muscle at level of T5. Group (D)/ (II) :20 patient (Dexmetonidine group) : Patient will receive 20ml 0.25% levobupivacaineas above + 1μ/kg dexmedetomidine. Group (M) / (III) : 20 patient (magnesium slphate group) : Patient will receive 20ml 0.25% levobupivacaineas 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.

Interventions

PROCEDUREultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy

Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle

PROCEDUREultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy

Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle

PROCEDUREultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy

Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle

Sponsors

South Egypt Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
analgesia requirement24 hoursfirst request for analgesia and total analgesia requirements

Secondary

MeasureTime frameDescription
chronic pain assessment6 monthsAssessment of chronic pain at 1-3 and 6 month post-operatively using LANSS pain score. a score of 12 or more is suggestive of neuropathic pain.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026