Effects of Adding Dexamethasone Plus Ketamine to Bupivacine in Serrtatus Plane Block
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Serratus anterior plane block for MRM
Sponsored by
About this trial
This is an interventional other trial for Post Operative Pain focused on measuring Serratus ,analgesia ,ketamine
Eligibility Criteria
Inclusion Criteria: All female patient undergoing modified radical mastectomy Age from 20 to 60 years ASA physical status I,II and III class Exclusion Criteria: Refusal for SAPB. Defective coagulation. Infection at the site of injection. History of allergy to the study drugs
Sites / Locations
- Ahmed FakherRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Serratus anterior plane block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg)
Serratus anterior plane block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg).
Outcomes
Primary Outcome Measures
Post ooerative analgesia requirment
Total post-operative morphine consumption over the first 24 hours post-operative and difference between two groups.
Time of first analgesic request
The time to first request of analgesic postoperatively and difference between two groups.
Secondary Outcome Measures
Full Information
NCT ID
NCT05775393
First Posted
February 21, 2023
Last Updated
March 7, 2023
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05775393
Brief Title
Effects of Adding Dexamethasone Plus Ketamine to Bupivacine in Serrtatus Plane Block
Official Title
Effects of Adding Dexamethasone Plus Ketamine to Bupivacaine for Ultrasound Guided Serratus Plane Block as Analgesia in Major Breast Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
April 20, 2023 (Anticipated)
Study Completion Date
May 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This randomized, double-blind trial included 60 female patients undergoing modified radical mastectomy. The study carried out at National Cancer Institute, cairo university after approval of the local ethical committee.
The study aiming to compare the analgesic efficiency of adding dexamethasone or ketamine plus dexamethasone to bupivacaine in ultrasound-guided serratus anterior plane block (SAPB) performed with modified radical mastectomy surgery.
Detailed Description
They will randomly assigned to two groups of 30 patients each, at 1:1 allocation ratio using computer-generated random numbers concealed in sealed opaque envelopes.
Group (A):
Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg).
Group (B):
Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg).
All the medications were prepared by an anesthesiologist not participating in the study.
Preoperative visit :
All cases will be assessed for any hemodynamic abnormalities in the preoperative room. Patient will be informed about the purpose and the content of the study before surgery. An informed consent |will be obtained from the participants.
Anesthetic technique :
General anesthesia A uniform anesthetic technique was used in two groups, namely, after pre oxygenation with 100% oxygen for 3 mints, induction of anesthesia will be by IV propofol 2 mg/kg, fentanyl 200 μg and atracurium 0.5 mg/kg to facilitate endotracheal intubation.
Anesthesia will be maintained with isoflurane 1-2% in 50% air in oxygen mixtures. Intermittent dose of atracurium for muscle relaxation and fentanyl will be used if heart rate increased more than 20% of initial HR.
All patients will be mechanically ventilated to maintain end-tidal carbon dioxide tension around 35 mmHg.
After induction of general anesthesia, ultrasound-guided SAPB will be done. Technique of SAPB Patients will be placed in the lateral position with the diseased side up. A linear ultrasound transducer (10-12 MHz) is placed over the mid-clavicular region of the thoracic cage in a sagittal plane.
The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior).
As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle.
The needle (22G, 50-mm Tuohy needle) is introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle.
Under continuous ultrasound guidance, local anesthetic solution is injected and fanning of local anesthetic is observed.
All patients will be continuously monitored with 5 leads electrocardiogram (ECG), pulse oximetry, non-invasive blood pressure monitoring (NIBP), end-tidal CO2, and TOF.
Inhalation anesthetic will be discontinued at the end of surgery and neuromuscular blockade was reversed by IV injection of neostigmine 0.05 mg/kg with atropine 0.01 mg/kg after fulfilling the criteria for extubation. Patients were extubated and transferred to surgical ICU.
For postoperative pain management, all patients will receive intravenous (IV) paracetamol 1 gm every 6 hrs (Injectemol, Pharco B International, Pharma-tech) then morphine IV (2-4 mg) if required to keep VAS score less than 3.
Morphine consumption during the first 24 postoperative hours as a rescue drug was calculated.
Patients will be continuously monitored for heart rate, oxygen saturation and systemic blood pressure and we will record every 10 min for the initial 1 hr. of the blockade; every 30 mints for the next 2 hrs. And then 2 hourly for the next 12 hrs.
As soon as the patient is alert enough, VAS score of pain (10 mm vertical scale from 0 to 10 where zero means no pain and 10 is the worst pain) was recorded every 2 hrs.
Sedation was assessed using the observer's assessment of alertness/sedation (OAA/S) scale.
The scale was scored as a composite score ranging from 1 (deep sleep) to 5 (alert).
Signs of morphine side effects (nausea, vomiting, dizziness, an unusual pleasant feeling, sweating, headache, anxiety, and constipation) will be monitored.
In case of nausea and/or vomiting, 10 mg metoclopramide was given intravenously.
Signs of side effects of SAPB as dyspnea, chest pain in case of pneumothorax and signs of local anesthetic toxicity will be monitored as arrhythmias , convulsions and circulatory collapse
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Serratus ,analgesia ,ketamine
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Serratus anterior plane block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg)
Arm Title
Group B
Arm Type
Experimental
Arm Description
Serratus anterior plane block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg).
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plane block for MRM
Intervention Description
They will randomly assigned to two groups of 30 patients each, at 1:1 allocation ratio using computer-generated random numbers concealed in sealed opaque envelopes.
Group (A):
Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg).
Group (B):
Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg).
All the medications were prepared by an anesthesiologist not participating in the study.
Primary Outcome Measure Information:
Title
Post ooerative analgesia requirment
Description
Total post-operative morphine consumption over the first 24 hours post-operative and difference between two groups.
Time Frame
24 hours
Title
Time of first analgesic request
Description
The time to first request of analgesic postoperatively and difference between two groups.
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All female patient undergoing modified radical mastectomy
Age from 20 to 60 years
ASA physical status I,II and III class
Exclusion Criteria:
Refusal for SAPB.
Defective coagulation.
Infection at the site of injection.
History of allergy to the study drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Fakher
Phone
+201097419966
Email
ahmezfakhr66@gmail.com
Facility Information:
Facility Name
Ahmed Fakher
City
Cairo
State/Province
Matareya
ZIP/Postal Code
11756
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Fakher
Phone
+201097419966
Email
ahmezfakhr66@gmail.com
12. IPD Sharing Statement
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Effects of Adding Dexamethasone Plus Ketamine to Bupivacine in Serrtatus Plane Block
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