Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion

Assiut University

Status and phase: Completed; Phase 1

Conditions: Cancer, Breast

Treatments: Drug: Lidocaine; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03502395

IRB0000871246

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Group I

Active Comparator group

Description:

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).

Treatment:

Drug: Lidocaine

Group II

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal saline