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

South Egypt Cancer Institute60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Postoperative

Interventions

ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomyPROCEDURE

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

ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomyPROCEDURE

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

South Egypt Cancer Institute

Asyut, Egypt

Outcomes

Primary Outcomes

analgesia requirement

first request for analgesia and total analgesia requirements

Time frame: 24 hours

Secondary Outcomes

chronic pain assessment

Assessment 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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