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Completed

NCT Number: NCT03502395

Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion

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.

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Key information

Conditions

Cancer, Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

): 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).

Other names: Active group

normal saline

Drug

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.

Other names: Placebo group

Primary outcomes

  1. Serum Opiorphin level

    Time frame: 24 hours postoperative

    Measuring the opiorphin blood level

Secondary outcomes

  1. Visual analog pain score

    Time frame: 24 hours postoperative

    Measure pain intensity. Graded from 0=no pain to 10=worst pain

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2018
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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