Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion

Cancer, Breast Clinical Trial

Official title:

Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion and Its Relation to Post-mastectomy Pain: a Prospective Double Blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502395
• Other study ID #: IRB0000871246
• Status: Completed
• Phase: Phase 1
• First received: April 11, 2018
• Last updated: April 17, 2018
• Start date: April 4, 2017
• Est. completion date: February 13, 2018

Study information

• Verified date: April 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, ASA I or II were included in the study.

• Group I (lidocaine): 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).

• Group II (control):- 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 13, 2018
• Est. primary completion date: January 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, American society of Anesthesiologist I or II

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast

Intervention

Drug:
• Lidocaine
): 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).
• Normal saline
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.

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Opiorphin level	Measuring the opiorphin blood level	24 hours postoperative
Secondary	Visual analog pain score	Measure pain intensity. Graded from 0=no pain to 10=worst pain	24 hours postoperative