Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion
1 other identifier
interventional
80
1 country
1
Brief Summary
A prospective, double blinded and randomized study included women with breast cancer and underwent mastectomy, and randomly allocated into two groups of equal size. Lidocaine group and control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2017
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
April 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2018
CompletedFirst Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedApril 19, 2018
April 1, 2018
10 months
April 11, 2018
April 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Serum Opiorphin level
Measuring the opiorphin blood level
24 hours postoperative
Secondary Outcomes (1)
Visual analog pain score
24 hours postoperative
Study Arms (2)
Group I
ACTIVE COMPARATORPatients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure).
Group II
PLACEBO COMPARATORA standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion.
Interventions
): Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure).
A standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion.
Eligibility Criteria
You may qualify if:
- Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, American society of Anesthesiologist I or II
You may not qualify if:
- Patients with contralateral breast cancer, metastatic tumor, morbid obesity (BMI\> 40), allergy to an amide local anesthetic, or morphine sulphate, heart block, renal, or liver dysfunction, or substance abuse disorder, or chronic opioid use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university faculty of medicine
Asyut, Egypt
Related Publications (1)
Rougeot C, Robert F, Menz L, Bisson JF, Messaoudi M. Systemically active human opiorphin is a potent yet non-addictive analgesic without drug tolerance effects. J Physiol Pharmacol. 2010 Aug;61(4):483-90.
PMID: 20814077RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abdelrady S Ibrahim, M.D.
Assiut University faculty of medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
April 11, 2018
First Posted
April 18, 2018
Study Start
April 4, 2017
Primary Completion
January 21, 2018
Study Completion
February 13, 2018
Last Updated
April 19, 2018
Record last verified: 2018-04