Rhomboid Intercostal and Subserratus Plane Block
Primary Purpose
Postoperative Pain, Regional Anesthesia Morbidity
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Control group
Rhomboid intercostal and subserratus plane block group
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring Radical Mastectomy, Postoperative pain, Morphine consumption, subserratus plane block
Eligibility Criteria
Inclusion Criteria:
- Female patients
- Aged 40-75 years
- ASA class I-II
- Presented for elective radical mastectomy.
Exclusion Criteria:
- Patients refused to participate.
- Patients with known or suspected allergy to the used medication.
- Patients with preoperative chronic pain
- Patients received preoperative opioids or gabapentoids.
- Patients with major cardiac, renal, respiratory, or hepatic disease.
- Patients with potential risk of coagulopathy
- Uncooperative patients.
- Obese patients with BMI >36
Sites / Locations
- Tanta University hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control group
Rhomboid intercostal and subserratus plane block group
Arm Description
The patients in this group will receive sham rhomboid intercostal and subserratus plane.
The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
Outcomes
Primary Outcome Measures
The postoperative morphine consumprtion
3 mg morphine i.v will be given when the postoperative VAS score was 4 or more considering the total dose consumption in the first postoperative day not exceeding 15 mg
Secondary Outcome Measures
The postoperative pain score
The postoperative Visual analogue score
Full Information
NCT ID
NCT04085263
First Posted
September 9, 2019
Last Updated
September 10, 2022
Sponsor
Tanta University
Collaborators
Dr. Mohamed shebl Abdelghany
1. Study Identification
Unique Protocol Identification Number
NCT04085263
Brief Title
Rhomboid Intercostal and Subserratus Plane Block
Official Title
The Effect of Rhomboid Intercostal and Subserratus Plane Block on the Postoperative Analgesia of Patients Undergoing Radical Mastectomy: Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 6, 2022 (Actual)
Study Completion Date
September 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
Dr. Mohamed shebl Abdelghany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial will be conducted at Tanta University Hospitals, General Surgery Hospitals on female patients undergoing radical mastectomy
. All the patients will receive general anesthesia.
The patients will be randomly allocated into one of the following two groups;- - Control group (30 patients): The patients in this group will receive sham rhomboid intercostal and subserratus plane.
- Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
The primary outcome measure will be the total dose of morphine consumed in the first 24 h after surgery and the secondary outcome will be the postoperative pain score.
Detailed Description
This prospective randomized controlled study will be carried out on female patients who will be presented for radical mastectomy in the general surgery department in Tanta university hospitals over three month duration and 6 months follow up that starts immediately after obtaining ethical committee approval, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
Any unexpected risks that will appear during the research will be announced to the participants and to the ethical committee at time and adequate measures will be taken to resolve and avoid these risks.
Expected risks to the patients: patients enrolled in this study will minimal risk of local hematoma that which will be managed by adequate compression and minimal risk of infection that will be guarded against by adequate sterilization and prophylactic antibiotic.
There will be adequate supervision to maintain the privacy of patients and confidentiality of data.
There will be no conflict of interest, nor conflict with religion, law, or society standards.
The research will be beneficial to the society and has no risk of environmental pollution.
Upon arrival of the patient to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached. After positioning and adequate sterilization of the back. The patients will be randomly allocated into two equal groups by the aid of computer-generated software of randomization; - • Control group (30 patients): The patients in this group will receive sham rhomboid intercostal and subserratus plane.
• Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
Anesthesia will be induced by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and cis-atracurium 0.15 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to a mechanical ventilator with its parameters adjusted to maintain etCo2 32-36 mmhg. Anesthesia will be maintained by isoflurane 1% MAC in mixture of oxygen:air 1:1 with the use of low flow (1 ml/min).
All the patients will be connected to a bispectral index monitor with maintaining its value ranging 40-60. Increase in the BIS value over 60 will be managed by additional dose of fentanyl 1ug/kg till decrease the BIS below 60. If the BIS is still over 60, increasing the isoflurane 0.2 % MAC till it decreased below 60.
At the end of the surgery, switching off the inhalational anesthetics, reversal of muscle relaxation, and awake tracheal extubation will be done with transporting the patients to the PACU for postoperative follow up and monitoring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Regional Anesthesia Morbidity
Keywords
Radical Mastectomy, Postoperative pain, Morphine consumption, subserratus plane block
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The participants will be kept blind through the use of sham block in the control group.
Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.
The investigators will be blinded
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
The patients in this group will receive sham rhomboid intercostal and subserratus plane.
Arm Title
Rhomboid intercostal and subserratus plane block group
Arm Type
Experimental
Arm Description
The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
Intervention Type
Procedure
Intervention Name(s)
Control group
Other Intervention Name(s)
Sham block group
Intervention Description
The patients in this group will receive sham rhomboid intercostal and subserratus plane.
Intervention Type
Procedure
Intervention Name(s)
Rhomboid intercostal and subserratus plane block group
Other Intervention Name(s)
Experimental group
Intervention Description
The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
Primary Outcome Measure Information:
Title
The postoperative morphine consumprtion
Description
3 mg morphine i.v will be given when the postoperative VAS score was 4 or more considering the total dose consumption in the first postoperative day not exceeding 15 mg
Time Frame
The first 24 hours postoperatively
Secondary Outcome Measure Information:
Title
The postoperative pain score
Description
The postoperative Visual analogue score
Time Frame
The first 24 hours postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients
Aged 40-75 years
ASA class I-II
Presented for elective radical mastectomy.
Exclusion Criteria:
Patients refused to participate.
Patients with known or suspected allergy to the used medication.
Patients with preoperative chronic pain
Patients received preoperative opioids or gabapentoids.
Patients with major cardiac, renal, respiratory, or hepatic disease.
Patients with potential risk of coagulopathy
Uncooperative patients.
Obese patients with BMI >36
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Ismaiel, M.D
Organizational Affiliation
Lecturer of Anesthesia and Intensive Care, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University hospitals
City
Tanta
ZIP/Postal Code
31511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Once the study had been successfully completed, the data will be shared for other researchers.
Learn more about this trial
Rhomboid Intercostal and Subserratus Plane Block
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