Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Serratus Anterior Plane Block Technique
General anesthesia
bupivacaine +ketamine
bupivacaine + neostigmine
bupivacaine +saline
Sponsored by

About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Faculty of medicine-Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
ketamine
Neostigmine
Control
Arm Description
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline.
Outcomes
Primary Outcome Measures
Time of first request of analgesia
it will be calculated from the time of complete injection of local anesthetics till the numerical rating scale (NRS) is ≥3.
Secondary Outcome Measures
The total amount of morphine consumption
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04544228
Brief Title
Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2020 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ketamine
Arm Type
Experimental
Arm Description
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine
Arm Title
Neostigmine
Arm Type
Experimental
Arm Description
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline.
Intervention Type
Procedure
Intervention Name(s)
Serratus Anterior Plane Block Technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
bupivacaine +ketamine
Other Intervention Name(s)
ketamine
Intervention Description
30 ml bupivacaine 0.25% + 1 ml ketamine (50mg) in Serratus Anterior Plane Block.
Intervention Type
Drug
Intervention Name(s)
bupivacaine + neostigmine
Other Intervention Name(s)
neostigmine
Intervention Description
30 ml bupivacaine 0.25% + 1 ml neostigmine (500 μg)in Serratus Anterior Plane Block.
Intervention Type
Drug
Intervention Name(s)
bupivacaine +saline
Other Intervention Name(s)
saline
Intervention Description
30 ml bupivacaine 0.25% + 1 ml normal saline in Serratus Anterior Plane Block.
Primary Outcome Measure Information:
Title
Time of first request of analgesia
Description
it will be calculated from the time of complete injection of local anesthetics till the numerical rating scale (NRS) is ≥3.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
The total amount of morphine consumption
Description
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.
Time Frame
24 hours postoperative
Title
Total amount of intraoperative fentanyl.
Description
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.
Time Frame
2 hours
Title
Numeric Pain Rating Scale
Description
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
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine-Cairo University
City
Cairo
ZIP/Postal Code
1772
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29720754
Citation
El Mourad MB, Amer AF. Effects of adding dexamethasone or ketamine to bupivacaine for ultrasound-guided thoracic paravertebral block in patients undergoing modified radical mastectomy: A prospective randomized controlled study. Indian J Anaesth. 2018 Apr;62(4):285-291. doi: 10.4103/ija.IJA_791_17.
Results Reference
background
PubMed Identifier
27746548
Citation
Pandey V, Mohindra BK, Sodhi GS. Comparative evaluation of different doses of intrathecal neostigmine as an adjuvant to bupivacaine for postoperative analgesia. Anesth Essays Res. 2016 Sep-Dec;10(3):538-545. doi: 10.4103/0259-1162.180779.
Results Reference
background
PubMed Identifier
23923989
Citation
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
Results Reference
background
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Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
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