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

Phase 2

• Conditions: Pain, Postoperative
• Interventions: Procedure: ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy; Procedure: ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy; Procedure: ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy

• Registration Number: NCT04732364
• Lead Sponsor: South Egypt Cancer Institute

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.

Study Timeline

• Study Start: 2018-04-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-28
• Last Update Submitted: 2021-01-28
• Study First Posted: 2021-02-01
• Last Update Posted: 2021-02-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (C) (control group):	ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy	Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.
Group (M) (magnesium slphate group):	ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy	Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5..
Group (D) (Dexmetonidine group):	ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy	Patient will receive 20ml 0.25% levobupivacaine + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5..

Primary Outcome Measures

Name	Time	Method
analgesia requirement	24 hours	first request for analgesia and total analgesia requirements

Secondary Outcome Measures

Name	Time	Method
chronic pain assessment	6 months	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.

Trial Locations

Locations (1)

South Egypt Cancer Institute; 🇪🇬 Assiut, Egypt