Aalgesic Efficacy of Erector -Spinae Technique With Levobupvicaine in Patients Undergoing Upper Abdominal Cancer Surgery
The Analgesic Efficacy of Erector -Spinae Technique With Levobupvicaine in Patients Undergoing Upper Abdominal Cancer Surgery
1 other identifier
interventional
30
1 country
1
Brief Summary
To study analgesic efficacy \&safety of bilateral erector spinae block for upper abdominal cancer surgery as apart of multimodal analgesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2019
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
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 13, 2020
CompletedFirst Posted
Study publicly available on registry
March 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedMarch 19, 2020
March 1, 2020
1.5 years
March 13, 2020
March 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
morphine consumption
Decrease morphine consumption.
24 hours
Secondary Outcomes (4)
VAS score
24 hours
patient satisfaction
24 hours
Hemodynamic
24 hours
blood gas
24 hours
Study Arms (2)
Group A
PLACEBO COMPARATORpatients will receive 20 ml of normal saline into interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side.
Group B
EXPERIMENTALPatients will receive 20 mg 0.25% Levobupivacaine into the interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side.
Interventions
A group of patients will receive 20 ml of normal saline into the interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side, the other group of patients will receive 20 mg 0.25% Levobupivacaine bilaterally as above 10 mg each side.
Eligibility Criteria
You may qualify if:
- Patient subjected to major upper abdominal cancer surgery.
- The enrolled age will be from 18-70 years old.
- ASA: I-III, NYHA: I-III.
You may not qualify if:
- ASA \& physical status (NYHA) \> III.
- Pregnant women.
- Body mass index \>40 kg/m2.
- Pre-operative opioid consumption.
- Contraindication or patient's refusal of the procedure.
- Un co-operative patient.
- Coagulopathy, skin infection, significant organ dysfunction or drug allergy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer Institute
Asyut, 171516, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Romany G. Rezk, MSc
Specialist
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- anesthesia specialist
Study Record Dates
First Submitted
March 13, 2020
First Posted
March 19, 2020
Study Start
June 1, 2019
Primary Completion
December 1, 2020
Study Completion
April 1, 2021
Last Updated
March 19, 2020
Record last verified: 2020-03