- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04531215
Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia
Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimized, as in a number of women it may chronically persist for months in the form of post-mastectomy pain syndrome.
Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties.
The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.
As percent of post-operative rescue analgesia is 16.7% and 60% for RLB group and ESPB group respectively. So, sample size is 46 patients (23 patients in each group). Sample was calculated using OPEN EPI program with confidence level 95% and power 80%.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mai Alahmady, MBBCH
- Phone Number: 002 01000314543
- Email: alahmadymai@gmail.com
Study Contact Backup
- Name: Alshaimaa Kamel, M.D
- Phone Number: 002 01005593169
- Email: AlshaimaaKamel80@yahoo.com
Study Locations
-
-
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Zagazig, Egypt
- Recruiting
- Zagazig University, Faculty of medicine
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Contact:
- Alshaimaa Kamel, M.D
- Phone Number: 002 01005593169
- Email: AlshaimaaKamel80@yahoo.com
-
Principal Investigator:
- Alshaimaa Kamel, M.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient acceptance.
- 21 - 64 years of age.
- American Society of Anesthesiologist physical status class I,II.
- Body Mass Index 25-35 kg/m2.
- Female patient undergoing elective unilateral modified radical mastectomy under general anesthesia.
Exclusion Criteria:
- Coagulation disorders or anticoagulant therapy.
- Known allergy to study drugs (Bupivacaine, Fentanyl)
- Infection at the injection site.
- Patients having chronic pain or on pain treatment.
- Advanced renal, respiratory, hepatic or cardiovascular disorders.
- Uncooperative patients.
- Duration of surgery > 3hours.
- Pregnant or lactating females.
- Metastasis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ultrasound guided Retrolaminar Block
ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
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ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side
|
Active Comparator: ultrasound guided erector spinae
ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
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ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total fentanyl dose.
Time Frame: from induction to end of surgery
|
The anesthesiologist will administer intravenous fentanyl 0.5 μg/kg when the heart rate or blood pressure of the patients increased >20% from basal measurements after exclusion of other causes.
|
from induction to end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity by Visual Analogue Scale
Time Frame: at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.
|
• Static and dynamic pain scores (VAS) at 30 minutes, 2, 4, 8, 12, 18 and 24 hours post-operatively. pain intensity will be evaluated by Visual Analogue Scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient will be asked to mark on this line where the intensity of the patient lies. |
at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.
|
Time of requirement of rescue dose of Fentanyl.
Time Frame: up to 24hour postoperative
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Time of requirement of rescue dose of Fentanyl.
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up to 24hour postoperative
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Total amount of postoperative Fentanyl
Time Frame: up to 24hour postoperative
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Total amount of Fentanyl consumed during the first 24 hours after surgery.
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up to 24hour postoperative
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Post-operative nausea and vomiting
Time Frame: up to 24hour postoperative
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• Post-operative nausea and vomiting will be noticed, recorded using a categorical scoring system (0 = none, 1 = mild, 2 = moderate, 3 = severe) and treated, Ondansetron 4 mg IV will be administered in case of reported nausea and/or vomiting
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up to 24hour postoperative
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Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
Time Frame: up to 24hour postoperative
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Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
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up to 24hour postoperative
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Overall patient satisfaction
Time Frame: up to 24hour postoperative
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• Overall patient satisfaction at the end of the 24 hours post-operative using short assessment patient satisfaction scale (SAPS scale fully satisfied, neutral satisfied or unsatisfied)
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up to 24hour postoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Alshaimaa Kamel, M.D, Zagazig University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6236 (CTEP)
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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