- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05518292
Comparison of Analgesic Efficacy of Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Mastectomy Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This double blinded randomized(closed envelope technique) study will be conducted on eighty ASA I and II female patients aged between 20-60 years, undergoing modified radical mastectomy surgeries at Oncology Center Mansoura University (OCMU). The study will start at September 2022 and the recruitment will take approximately five months. The study duration can take about eight months. All patients undergoing general anesthesia. Informed consent will be taken after approval by the local ethics committee. The exclusion criteria included local skin infection , bleeding disorder ,coagulation abnormality ,spine or chest deformity , psychiatric disease, pregnancy and patients with allergy to any of the drug used .
Patients will be randomly assigned to either two groups according to the block used either rhomboid plane block in group R (n=30) received total volume of 20 ml of bupivacain 0.25% or serratus plane block group S (n=30) received total volume of 20 ml of bupivacaine 0.5% . The observer anesthetist and the surgeon were blinded to the solution. Operation will be performed by the same surgeon .Anesthetic management will be standardized and all patients will be premedicated with diazepam 5mg per orally at the morning of the surgery. Induction will be started with preoxygenation for 3 min, anesthesia will be induced with fentanyl (2ug/kg), 2 mg/kg propofol, muscle relaxation will be achieved by atracurium 0.05 mg kg and tracheal intubation will be achieved using suitable size of endotracheal tube . Anesthesia will be maintained with minimum alveolar concentration(MAC ) of isoflurane with air - oxygen and fentanyl 1µg/kg boluses and atracurium 0.2 mg/kg to maintain heart rate and pressure within 20% of their baseline values, the patients' lungs will be ventilated to maintain an ETCO2 of 30-35 mmHg. . Isoflurane will be discontinued at the start of skin closure, residual neuromuscular block will be antagonized with neostigmine 0.05 mg kg and atropine 0.025 mg kg and the trachea will be extubated. Heart rate ,end-tidal CO2, pulse oximetry and systolic blood pressure and diastolic blood pressure will be recorded before induction of anesthesia (baseline) and after induction of anesthesia then every 5min during surgery till end of surgery .
Post operative assessment:
In the PACU , patients were monitored for heart rate ,oxygen saturation ,systolic blood pressure and diastolic blood pressure for 1 hour postoperative by another anesthetist who was not aware of the study protocol . Patients were discharged to the surgical ward if they achieved score of 10 at modified Aldrete score .
Postoperative severity of pain which was assessed using VAS 1/2 hour after surgery, then at 1h, 2h, 4h, 6 h, 8h,12h and 24 h postoperatively . All patients were given IV ketorolac 30 mg/8 hour postoperatively and IV fentanyl 0.5µg/kg was available as rescue analgesia whenever VAS continued to be>40 mm after 30 min of ketorolac injection. Fentanyl injection could be repeated. The time for the first postoperative analgesic dose requirements and the total dose of 24hour postoperative fentanyl consumption were recorded . Postoperative nausea and vomiting (PONV) were assessed using a four-point numerical scale (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once), postoperative adverse effects and complications were recorded .
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
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Mansoura, Egypt
- Recruiting
- Yahya Wahba
-
Principal Investigator:
- Tamer E abdallah, assist prof
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I and II
- female patients
- aged between 20-60 years,
- undergoing modified radical mastectomy surgeries
Exclusion Criteria:
- local skin infection ,
- bleeding disorder ,
- coagulation abnormality ,
- spine or chest deformity ,
- psychiatric disease,
- pregnancy
- patients with allergy to any of the drug used
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: rhomboid intercostal block
Ultrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique.
Patients will placed in the sitting position.
22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula.
20 ml of bupivacaine 0.25% will inject into the fascial plane.
|
Ultrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique.
Patients will placed in the sitting position.
22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula.
20 ml of bupivacaine 0.25% will inject into the fascial plane.
|
ACTIVE_COMPARATOR: serratus anterior plane block
Patients will placed in the lateral position with the diseased side up.
A 10-12 MHz linear ultrasound transducer 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 spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle.
Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject.
|
Patients will placed in the lateral position with the diseased side up.
A 10-12 MHz linear ultrasound transducer 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 spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle.
Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
numerical analog score
Time Frame: half hour after finishing mastectomy
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0= no pain 10=sever pain
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half hour after finishing mastectomy
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numerical analog score
Time Frame: 1 hour after finishing mastectomy
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0= no pain 10=sever pain
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1 hour after finishing mastectomy
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numerical analog score
Time Frame: 4 hour after finishing mastectomy
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0= no pain 10=sever pain
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4 hour after finishing mastectomy
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numerical analog score
Time Frame: 8 hour after finishing mastectomy
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0= no pain 10=sever pain
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8 hour after finishing mastectomy
|
numerical analog score
Time Frame: 12 hour after finishing mastectomy
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0= no pain 10=sever pain
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12 hour after finishing mastectomy
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numerical analog score
Time Frame: 24 hour after finishing mastectomy
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0= no pain 10=sever pain
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24 hour after finishing mastectomy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
required analgesia
Time Frame: half hour after mastectomy
|
numerical analog score more than 4
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half hour after mastectomy
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R.22.09.1830
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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