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

Primary Purpose

Analgesia, Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound (US) bi-level erector spinae block
levobupivacaine
Ketamine
Magnesium Sulfate
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Analgesia

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • south Egypt Cancer Institute Assiut University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group (C) (control group)

Group (K) (Ketamine group)

Group (M) (magnesium sulphate group)

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

total morphine consumption in first 48 hours
determine the analgesic effect of ketamine and magnesium sulphate in decreasing morphine consumption
time to first request of analgesia

Secondary Outcome Measures

Full Information

First Posted
February 14, 2020
Last Updated
April 15, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04275661
Brief Title
Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (C) (control group)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Group (K) (Ketamine group)
Arm Type
Experimental
Arm Description
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
Arm Title
Group (M) (magnesium sulphate group)
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Ultrasound (US) bi-level erector spinae block
Intervention Description
nerve block
Intervention Type
Drug
Intervention Name(s)
levobupivacaine
Intervention Description
20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
2 mg /kg ketamine.injected into fascial plane deep to erector spinae muscle
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
2mg/kg Magnesium Sulfate .injected into fascial plane deep to erector spinae muscle
Primary Outcome Measure Information:
Title
total morphine consumption in first 48 hours
Description
determine the analgesic effect of ketamine and magnesium sulphate in decreasing morphine consumption
Time Frame
48 hours
Title
time to first request of analgesia
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khaled fares
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
hamdy abbas
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
fatma adel
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
south Egypt Cancer Institute Assiut University
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
31227568
Citation
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.
Results Reference
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PubMed Identifier
31044575
Citation
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.
Results Reference
background
PubMed Identifier
29980005
Citation
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.
Results Reference
background

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

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