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Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03502395
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
10.3
Actual Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion and Its Relation to Post-mastectomy Pain: a Prospective Double Blinded Study
Actual Study Start Date :
Apr 4, 2017
Actual Primary Completion Date :
Jan 21, 2018
Actual Study Completion Date :
Feb 13, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group I

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).

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).
Other Names:
  • Active group

    		•
    Placebo Comparator: Group II

    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.

    Drug: 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.
    Other Names:
  • Placebo group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum Opiorphin level [24 hours postoperative]

      Measuring the opiorphin blood level

    Secondary Outcome Measures

    1. Visual analog pain score [24 hours postoperative]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university faculty of medicine Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Abdelrady S Ibrahim, M.D., Assiut University faculty of medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdelrady S Ibrahim, MD, Assistant professor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03502395
    Other Study ID Numbers:
    • IRB0000871246
    First Posted:
    Apr 18, 2018
    Last Update Posted:
    Apr 19, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Lidocaine

    Study Results

    No Results Posted as of Apr 19, 2018