Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery

NCT04275661 | Completed Phase 2

• 1 other identifier: ESPB in breast cancer surgery
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim will be to compare the analgesic efficacy and safety of ketamine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy.

Conditions

Analgesia; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• total morphine consumption in first 48 hours

  determine the analgesic effect of ketamine and magnesium sulphate in decreasing morphine consumption

  48 hours

• time to first request of analgesia

  48 hours

Study Arms (3)

Group (C) (control group)

PLACEBO COMPARATOR

Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7.

Procedure: Ultrasound (US) bi-level erector spinae block; Drug: levobupivacaine

Group (K) (Ketamine group)

EXPERIMENTAL

Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg ketamine at each level with total dose 2mg/kg

Procedure: Ultrasound (US) bi-level erector spinae block; Drug: levobupivacaine; Drug: Ketamine

Group (M) (magnesium sulphate group)

EXPERIMENTAL

Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg MgSo4 at each level with total dose 2mg/kg

Procedure: Ultrasound (US) bi-level erector spinae block; Drug: levobupivacaine; Drug: Magnesium Sulfate

Interventions

Ketamine DRUG

2 mg /kg ketamine.injected into fascial plane deep to erector spinae muscle

Group (K) (Ketamine group)

Magnesium Sulfate DRUG

2mg/kg Magnesium Sulfate .injected into fascial plane deep to erector spinae muscle

Group (M) (magnesium sulphate group)

Ultrasound (US) bi-level erector spinae block PROCEDURE

nerve block

Group (C) (control group); Group (K) (Ketamine group); Group (M) (magnesium sulphate group)

levobupivacaine DRUG

20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle

Group (C) (control group); Group (K) (Ketamine group); Group (M) (magnesium sulphate group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age of 18 - 60 years.
• ASA grade I - II.

You may not qualify if:

• Patient refusal. known allergy to the study drugs skin infection at site of needle puncture significant organ dysfunction Coagulopathy drug or alcohol abuse psychiatric illness that would interfere with perception and assessment of pain.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

south Egypt Cancer Institute Assiut University

Asyut, Egypt

Location

Related Publications (3)

• Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Bi-level erector spinae plane block for the control of severe back pain related to vertebral metastasis. BMJ Case Rep. 2019 Jun 20;12(6):e228129. doi: 10.1136/bcr-2018-228129.

  PMID: 31227568 BACKGROUND

• Kwon WJ, Bang SU, Sun WY. Erector Spinae Plane Block for Effective Analgesia after Total Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. J Korean Med Sci. 2018 Nov 5;33(45):e291. doi: 10.3346/jkms.2018.33.e291. No abstract available.

  PMID: 31044575 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

MeSH Terms

Conditions

Agnosia; Breast Neoplasms

Interventions

High-Energy Shock Waves; Levobupivacaine; Ketamine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• khaled fares

  Assiut University

  STUDY DIRECTOR

• hamdy abbas

  Assiut University

  STUDY DIRECTOR

• fatma adel

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 19, 2020
• Study Start: August 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: April 30, 2022
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

EG (1)