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Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion

Primary Purpose

Cancer, Breast

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Lidocaine

Normal saline

About this trial

This is an interventional prevention trial for Cancer, Breast

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Assiut university faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group I

Group II

Arm 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).

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.

Outcomes

Primary Outcome Measures

Serum Opiorphin level

Measuring the opiorphin blood level

Secondary Outcome Measures

Visual analog pain score

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

Full Information

NCT ID

NCT03502395

First Posted

April 11, 2018

Last Updated

April 17, 2018

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03502395

Brief Title

Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

April 4, 2017 (Actual)

Primary Completion Date

January 21, 2018 (Actual)

Study Completion Date

February 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Breast

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Active Comparator

Arm Description

Arm Title

Group II

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Other Intervention Name(s)

Active group

Intervention 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).

Intervention Type

Drug

Intervention Name(s)

Normal saline

Other Intervention Name(s)

Placebo group

Intervention 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.

Primary Outcome Measure Information:

Title

Serum Opiorphin level

Description

Measuring the opiorphin blood level

Time Frame

24 hours postoperative

Secondary Outcome Measure Information:

Title

Visual analog pain score

Description

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

Time Frame

24 hours postoperative

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Women with breast cancer and underwent mastectomy

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abdelrady S Ibrahim, M.D.

Organizational Affiliation

Assiut University faculty of medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assiut university faculty of medicine

City

Assiut

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

20814077

Citation

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.

Results Reference

result

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Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion

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