Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery
Efficacy and Safety of Ketamine Versus Magnesium Sulphate as Adjuvants to Levobupivacaine in Ultrasound (US) Bi-level Erector Spinae Block in Breast Cancer Surgery
Study Overview
Status
Conditions
Detailed Description
The participating females will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into one of 3 groups.
Group (C) / (I): 20 patients (control group):
Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and T7.
Group (K) / (II): 20 patients (Ketamine group):
Patient will receive 20ml 0.25% levobupivacaine as above + 2 mg /kg ketamine.
Group (M) / (III): 20 patients (magnesium sulphate group):
Patient will receive 20ml 0.25% levobupivacaine as above + 2mg/kg MgSo4.
Study protocol:
Premedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery. ECG, temp, and capnography), an intravenous cannula will be placed and secured in the opposite side to surgery.
Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (lt. or Rt.) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth and seventh spinous process, then Trapezious m., Rhomboideus major muscle, and erector spinae muscle, are identified from surface, we will deposite 20 ml of 0.25% levobupivacairen into interfacial plane below erector spinae muscle.
General anesthesia will be induced with lμg/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium inhalational anesthesia (isoflurane or sevoflurane)
1gm paracetamol after induction No other narcotic, analgesic or sedative will be administrated during operative period.
Standard monitor (MABP, HR , SaO2 & EtCo2) will be observed and recorded every 30 min till end of surgery Post-operative ; the patient will be transferred to the post anesthesia care unit (PACU). In PACU the following data included heart rate, mean blood pressure, respiratory rate and oxygen saturation and VAS scores (at rest and after movement in the form of abduction of ipsilateral arm ) at baseline,2,4,6,12,24 and 48 hours post-operatively to evaluate acute pain will be observed and recorded. The attending anesthesiologist, surgeon and the data collecting personal will be unaware of the patient assignment.
Rescue post-operative analgesia in the form of morphine Patient controlled analgesia (PCA ) with an initial bolus of 0.1 mg/ kg morphine once pain is expressed followed by 1mg bolus with a locked period of 15 minutes with no back ground infusion allowed. The time to first request of analgesia and the total analgesic consumption in the 1st 48 hour will be observed and recorded. Postoperative adverse effects will be observed and treated
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Asyut, Egypt
- south Egypt Cancer Institute Assiut University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age of 18 - 60 years.
- ASA grade I - II.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Group (C) (control group)
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.
|
nerve block
20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle
|
|
Experimental: Group (K) (Ketamine group)
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
|
nerve block
20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle
2 mg /kg ketamine.injected
into fascial plane deep to erector spinae muscle
|
|
Experimental: Group (M) (magnesium sulphate group)
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
|
nerve block
20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle
2mg/kg Magnesium Sulfate .injected
into fascial plane deep to erector spinae muscle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total morphine consumption in first 48 hours
Time Frame: 48 hours
|
determine the analgesic effect of ketamine and magnesium sulphate in decreasing morphine consumption
|
48 hours
|
|
time to first request of analgesia
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: hamdy abbas, Assiut University
- Study Director: khaled fares, Assiut University
- Study Director: fatma adel, Assiut University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neurobehavioral Manifestations
- Skin Diseases
- Breast Diseases
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Breast Neoplasms
- Agnosia
- Sulfur Compounds
- Organic Chemicals
- Hydrocarbons
- Cyclohexanes
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Physical Phenomena
- Anilides
- Amides
- Aniline Compounds
- Amines
- Inorganic Chemicals
- Sulfur Acids
- Radiation
- Radiation, Nonionizing
- Sulfates
- Sulfuric Acids
- Ultrasonic Waves
- Sound
- Bupivacaine
- Magnesium Compounds
- Levobupivacaine
- Ketamine
- Magnesium Sulfate
- High-Energy Shock Waves
Other Study ID Numbers
- ESPB in breast cancer surgery
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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