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Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy

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ClinicalTrials.gov Identifier: NCT04544228
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Bassant M. Abdelhamid, Cairo University

Tracking Information
First Submitted Date  ICMJE August 28, 2020
First Posted Date  ICMJE September 10, 2020
Last Update Posted Date September 23, 2020
Actual Study Start Date  ICMJE September 5, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2020)
Time of first request of analgesia [ Time Frame: 24 hours postoperative ]
it will be calculated from the time of complete injection of local anesthetics till the numerical rating scale (NRS) is ≥3.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2020)
  • The total amount of morphine consumption [ Time Frame: 24 hours postoperative ]
    Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 3. The total amount of morphine given in 24 hours will be recorded for the three groups.
  • Total amount of intraoperative fentanyl. [ Time Frame: 2 hours ]
    Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
  • Numeric Pain Rating Scale [ Time Frame: 24 hours ]
    A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
Official Title  ICMJE Comparison of Effectiveness of Adding Ketamine or Neostigmine to Bupivacaine for Ultrasound Guided Serratus Anterior Plane Block in Modified Radical Mastectomy , Randomized Double Blinded Comparative Study.
Brief Summary The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.
Detailed Description

Breast cancer is the most common malignancy among females with incidence of 18,660 patients each year in Egypt. Modified Radical Mastectomy is considered the main surgical management for breast cancer accounting for 31% of all breast surgery cases.

Ultrasound guided Serratus anterior plane block provides analgesia for breast and lateral thoracic wall surgeries by blocking nerves that are located in a compartment between the serratus anterior and the latissimus dorsi muscles ( the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve and thoracodorsal nerve).

A previous study demonstrated the analgesic efficacy of ketamine in patients undergoing modified pectoral nerve block in breast cancer surgery as evidenced by prolonged time to first rescue analgesia and reduced total opioid consumption.

Neostigmine has been used as an additive to local anesthetics to prolong the analgesic effect. Although there is good evidence for a spinal action of neostigmine, its analgesic efficacy as an adjuvant to local anesthetic is still unclear.

The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Procedure: Serratus Anterior Plane Block Technique
    The patient will be placed in Lateral Decubitus with a surgical side upwards with arm abduction. A linear ultrasound transducer (6-13 MHz) will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge regional block needle will be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. The expecting depth for this block is 1-4 cm. After aspiration, injection 30ml local anesthetic mixture will be injected anteriorly to the rib and deep to the serratus anterior muscle.
  • Procedure: General anesthesia

    Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.

    Anaesthesia will be maintained with inhaled sevoflurane 2-2.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium 0.1 m\kg will be provided every 30 minutes.

    The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.

  • Drug: bupivacaine +ketamine
    30 ml bupivacaine 0.25% + 1 ml ketamine (50mg) in Serratus Anterior Plane Block.
    Other Name: ketamine
  • Drug: bupivacaine + neostigmine
    30 ml bupivacaine 0.25% + 1 ml neostigmine (500 μg)in Serratus Anterior Plane Block.
    Other Name: neostigmine
  • Drug: bupivacaine +saline
    30 ml bupivacaine 0.25% + 1 ml normal saline in Serratus Anterior Plane Block.
    Other Name: saline
Study Arms  ICMJE
  • Experimental: ketamine
    Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine
    Interventions:
    • Procedure: Serratus Anterior Plane Block Technique
    • Procedure: General anesthesia
    • Drug: bupivacaine +ketamine
  • Experimental: Neostigmine
    Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine
    Interventions:
    • Procedure: Serratus Anterior Plane Block Technique
    • Procedure: General anesthesia
    • Drug: bupivacaine + neostigmine
  • Active Comparator: Control
    Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline.
    Interventions:
    • Procedure: Serratus Anterior Plane Block Technique
    • Procedure: General anesthesia
    • Drug: bupivacaine +saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 3, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ● Female patients

    • Type of surgery; Modified Radical Mastectomy (MRM).
    • Physical status ASA II, III.
    • Age ≥ 21 and ≤ 65 Years.
    • Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Exclusion Criteria:

  • ● Patients with Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).

    • History of psychological disorders and/or chronic pain.
    • Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
    • Infection of the skin at the site of needle puncture area
    • Patient refusal.
    • Severe respiratory or cardiac disorders.
    • Advanced liver or kidney disease.
    • Pregnancy.
    • Patient with surgery duration more than two hours
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bassant abdelhamid 01224254012 bassantmohamed197@yahoo.com
Contact: Ahmed Saad 01229781573 Abosaaddr@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04544228
Other Study ID Numbers  ICMJE MS-101-2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bassant M. Abdelhamid, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bassant abdelhamid, M.D. Cairo University
PRS Account Cairo University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP