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

April 15, 2022 updated by: Ali Rabiee Ali, Assiut University

Efficacy and Safety of Ketamine Versus Magnesium Sulphate as Adjuvants to Levobupivacaine in Ultrasound (US) Bi-level Erector Spinae Block in Breast Cancer Surgery

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • south Egypt Cancer Institute Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Procedure: Ultrasound (US) bi-level erector spinae block
nerve block
Drug: levobupivacaine
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
Procedure: Ultrasound (US) bi-level erector spinae block
nerve block
Drug: levobupivacaine
20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle
Drug: Ketamine
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
Procedure: Ultrasound (US) bi-level erector spinae block
nerve block
Drug: levobupivacaine
20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle
Drug: Magnesium Sulfate
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

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: hamdy abbas, Assiut University
  • Study Director: khaled fares, Assiut University
  • Study Director: fatma adel, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

March 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPB in breast cancer surgery

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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