Effects of Adding Dexamethasone Plus Ketamine to Bupivacine in Serrtatus Plane Block
1 other identifier
interventional
60
1 country
1
Brief Summary
This randomized, double-blind trial included 60 female patients undergoing modified radical mastectomy. The study carried out at National Cancer Institute, cairo university after approval of the local ethical committee. The study aiming to compare the analgesic efficiency of adding dexamethasone or ketamine plus dexamethasone to bupivacaine in ultrasound-guided serratus anterior plane block (SAPB) performed with modified radical mastectomy surgery.
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 2022
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
February 20, 2022
CompletedFirst Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2023
CompletedMarch 20, 2023
March 1, 2023
1.2 years
February 21, 2023
March 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Post ooerative analgesia requirment
Total post-operative morphine consumption over the first 24 hours post-operative and difference between two groups.
24 hours
Time of first analgesic request
The time to first request of analgesic postoperatively and difference between two groups.
24 hours
Study Arms (2)
Group A
EXPERIMENTALSerratus anterior plane block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg)
Group B
EXPERIMENTALSerratus anterior plane block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg).
Interventions
They will randomly assigned to two groups of 30 patients each, at 1:1 allocation ratio using computer-generated random numbers concealed in sealed opaque envelopes. Group (A): Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg). Group (B): Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg). All the medications were prepared by an anesthesiologist not participating in the study.
Eligibility Criteria
You may qualify if:
- All female patient undergoing modified radical mastectomy
- Age from 20 to 60 years
- ASA physical status I,II and III class
You may not qualify if:
- Refusal for SAPB.
- Defective coagulation.
- Infection at the site of injection.
- History of allergy to the study drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahmed Fakher
Cairo, Matareya, 11756, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 20, 2023
Study Start
February 20, 2022
Primary Completion
April 20, 2023
Study Completion
May 20, 2023
Last Updated
March 20, 2023
Record last verified: 2023-03