Dexamedatomidine vs. Dexamethasone in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery
Primary Purpose
Postoperative Pain, Acute
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rhomboid Intercostal and Sub-Serratus block technique (RISS)
General Anaesthesia
dexamedatomidine
dexamethasone
saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- Adult female patient
- 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:
- Patient refusal.
- Patients suffering from coagulation disorders.
- Patients with histories of allergic reactions to local anesthetics or dexmedetomidine.
- Patients suffering from neuropsychiatric disorders.
- Pregnancy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
dexamedatomidine
dexamethasone
saline
Arm Description
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
Outcomes
Primary Outcome Measures
Time of first request of analgesia.
calculated from the time of complete injection of local anesthetics till the numerical rating scale (is more than or equals 3
Secondary Outcome Measures
Total amount of morphine consumption
mean arterial blood pressure
heart rate
Numerical rating scale
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Full Information
NCT ID
NCT05385523
First Posted
May 18, 2022
Last Updated
May 25, 2022
Sponsor
Armed Forces College of Medicine, Cairo, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05385523
Brief Title
Dexamedatomidine vs. Dexamethasone in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery
Official Title
Comparison Between Analgesic Effect of Adding Dexamedatomidine or Dexamethasone to Bupvicaine in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2022 (Anticipated)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Armed Forces College of Medicine, Cairo, Egypt
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 evaluate the analgesic efficacy and safety of adding dexmedetomidine and dexamethasone to bupivacaine in rhomboidal intercostal and subserratus (RISS) block for patients undergoing modified radical mastectomy compared to bupivacaine only.
Detailed Description
Rhomboid intercostal block (RIB); a new interfascial plane block involves the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. The local anaesthetic spreads between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes.
Aiming to expand dermatomal coverage, a new modification of Rhomboid Intercostal and Sub-Serratus block (RISS) is performed by advancing the ultrasound probe caudally and laterally distal to the inferior angle of the scapula, the second injection apply between the serratus and intercostal muscle fascia. The RISS block is a novel ultrasound-guided block that has been shown to provide analgesia from T2-T11 dermatomes.
Dexmedetomidine is a potent selective α 2 adrenoceptor agonist that was reported in many previous studies as an adjunct to regional and general anesthesia, with significant prolongation of the duration of sensory block, motor block and analgesia, and accelerate the time to onset of sensory and motor block when added to a local anesthetic.
Dexamethasone is a potent long-acting steroid that has shown efficacy as an adjuvant to local anesthetics in various studies. It enhances peripheral nerve blocks when added to local anesthetics, providing better quality of anesthesia as well as postoperative analgesia. The mechanism by which dexamethasone prolong the duration of local anesthetics are not completely understood; however, some studies demonstrated that dexamethasone exerts its action through reducing the release of inflammatory mediators and by inhibiting discharge of C-fibers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dexamedatomidine
Arm Type
Experimental
Arm Description
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
Arm Title
dexamethasone
Arm Type
Experimental
Arm Description
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.
Arm Title
saline
Arm Type
Experimental
Arm Description
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
Intervention Type
Procedure
Intervention Name(s)
Rhomboid Intercostal and Sub-Serratus block technique (RISS)
Intervention Description
The patient will be placed in lateral position. A linear ultrasound transducer of frequency 6-12 MHz will be placed medial to the lower border of the scapula in a sagittal plane. A 38-mm 22-gauge will be inserted under real-time in-plane from craniocaudal between the rhomboid major and intercostal muscles. After negative aspiration, single injection of 10 ml of the local anesthetic mixture will be administered at the T6 7 level. The spread of local anesthetic solution under the rhomboid muscle will be visualized by ultrasonography. Then the ultrasound probe will be moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscle for the sub-serratus block at T 8-9 level. The needle will be advanced from its previous position and a further of 10 ml of the local anesthetic mixture will be injected.
Intervention Type
Procedure
Intervention Name(s)
General Anaesthesia
Intervention Description
Fentanyl (1 μg/kg), propofol (2-3mg/kg) and atracurium (0.3-0.5 mg/kg) will be injected intravenously 3-5 minutes after oxygenation. A single-lumen endotracheal tube will be used to complete ventilation. The ventilator ventilation mode is volume control mode, and the patient's end-expiratory carbon dioxide level is maintained at 35-40 mmHg throughout the anesthesia process. During the anesthesia maintenance phase, 2% sevoflurane mixed with 60% oxygen.
After general anaesthesia induction, all patients will receive RISS block with different local anesthetic drug mixture according to randomization.
Intervention Type
Drug
Intervention Name(s)
dexamedatomidine
Intervention Description
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
Primary Outcome Measure Information:
Title
Time of first request of analgesia.
Description
calculated from the time of complete injection of local anesthetics till the numerical rating scale (is more than or equals 3
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Total amount of morphine consumption
Time Frame
24 hours
Title
mean arterial blood pressure
Time Frame
24 hours
Title
heart rate
Time Frame
24 hours
Title
Numerical rating scale
Description
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult female patient
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:
Patient refusal.
Patients suffering from coagulation disorders.
Patients with histories of allergic reactions to local anesthetics or dexmedetomidine.
Patients suffering from neuropsychiatric disorders.
Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bassant Abdelhamid, MD
Phone
001224254012
Email
Bassantmohamed197@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah Homouda
Phone
001276745271
Email
Abdallahhamouda71@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassant Abdelhamid, MD
Organizational Affiliation
AFCM Egypt
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26330711
Citation
Kaur H, Singh G, Rani S, Gupta KK, Kumar M, Rajpal AS, Aggarwal S. Effect of dexmedetomidine as an adjuvant to levobupivacaine in supraclavicular brachial plexus block: A randomized double-blind prospective study. J Anaesthesiol Clin Pharmacol. 2015 Jul-Sep;31(3):333-8. doi: 10.4103/0970-9185.161668.
Results Reference
background
PubMed Identifier
28033159
Citation
Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.
Results Reference
background
PubMed Identifier
30703673
Citation
Elsharkawy H, Ince I, Pawa A. Rhomboid intercostal and sub-serratus (RISS) plane block for analgesia after lung transplant. J Clin Anesth. 2019 Sep;56:85-87. doi: 10.1016/j.jclinane.2019.01.042. Epub 2019 Jan 28. No abstract available.
Results Reference
result
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Dexamedatomidine vs. Dexamethasone in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery
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