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

NCT04732364 | Unknown Phase 2

• 1 other identifier: peter SECI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Erector Spinae Block; magnesium sulphate; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• analgesia requirement

  first request for analgesia and total analgesia requirements

  24 hours

Secondary Outcomes (1)

• chronic pain assessment

  6 months

Study Arms (3)

Group (C) (control group):

PLACEBO COMPARATOR

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

Procedure: ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy

Group (D) (Dexmetonidine group):

ACTIVE COMPARATOR

Patient will receive 20ml 0.25% levobupivacaine + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5..

Procedure: ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy

Group (M) (magnesium slphate group):

ACTIVE COMPARATOR

Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5..

Procedure: ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy

Interventions

ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy PROCEDURE

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

Group (C) (control group):

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

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

Group (D) (Dexmetonidine group):

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

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

Group (M) (magnesium slphate group):

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (1)

South Egypt Cancer Institute

Asyut, 171516, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Mastectomy, Modified Radical; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mastectomy, Radical; Mastectomy; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• peter R Edward, MSc

  specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: February 1, 2021
• Study Start: April 30, 2018
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

EG (1)