Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia
1 other identifier
interventional
46
1 country
1
Brief Summary
Thoracic epidural anesthesia (TEA) and paravertebral block (PVB) have been utilized to give perioperative regional anesthesia in the trunk. TEA is technically troublesome in some cases, and is associated with a danger of serious complications, such as epidural hematoma, nerve injury, and hypotension. PVB has the benefit of perception of the needle position using ultrasonography. However, PVB is also additionally connected with a danger of serious complications, such as pneumothorax, hypotension, or nerve injury. Newer approaches to deal with PVB have been the focal point of numerous techniques lately; these methodologies incorporate retrolaminar block (RLB) and erector spinae plane block (ESPB)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMarch 1, 2024
February 1, 2024
3.2 years
August 25, 2020
February 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Total fentanyl dose.
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 Outcomes (6)
pain intensity by Visual Analogue Scale
at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.
Time of requirement of rescue dose of Fentanyl.
up to 24hour postoperative
Total amount of postoperative Fentanyl
up to 24hour postoperative
Post-operative nausea and vomiting
up to 24hour postoperative
Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
up to 24hour postoperative
- +1 more secondary outcomes
Study Arms (2)
ultrasound guided Retrolaminar Block
ACTIVE COMPARATORultrasound 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.
ultrasound guided erector spinae
ACTIVE COMPARATORultrasound 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Patient acceptance.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zagazig University, Faculty of medicine
Zagazig, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alshaimaa Kamel, M.D
Zagazig University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
August 25, 2020
First Posted
August 28, 2020
Study Start
February 1, 2021
Primary Completion
March 30, 2024
Study Completion
April 1, 2024
Last Updated
March 1, 2024
Record last verified: 2024-02