Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block Has a System Analgesic Effect?

January 19, 2020 updated by: Fatma Adel El sherif,MD

Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block for Post Mastectomy Pain Has a System Analgesic Effect? A Clinical and Pharmacokinetics Study

the investigators aim is to investigate and explore the effect 10 mg morphine added to local anesthetics in serratus anterior plane block for post mastectomy pain management after modified radical mastectomy in patients with breast cancer with assessment of its serum level if it will be absorbed systemically or not?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assuit, Egypt, 171516
        • South Egypt Cancer Instuite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • (ASA) class I-II
  • body weight of 50 - 90 kg

Exclusion Criteria:

  • a history of bleeding diathesis,
  • relevant drug allergy, opioid dependence,
  • sepsis, prior surgery in the supraclavicular, infraclavicular or axillary regions, alcohol or drug abuse , patients with advanced cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: morphine sulphate
10mg locally morphine hydrochloride once betwwen serratus muscle and latissmus dorsi muscle
Drug: Morphine Sulfate
Other Names:
  • morphine
Placebo Comparator: bupivacaine hydrochloride
0.25%locally bupivacaine hydrochloride once
Drug: Bupivacaine Hydrochloride
Other Names:
  • marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum morphine level after local injection
Time Frame: 24 hours
concentration of serum morphine in ng/ml after local injection
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatma Adel El sherif,MD

Investigators

  • Study Director: fatma EL sherif, South Egypt Cancer Instuite, Assuit, Assuit university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 19, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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