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

NCT ID: NCT02962024

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

morphine sulphate

10mg locally morphine hydrochloride once betwwen serratus muscle and latissmus dorsi muscle

Group Type ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type DRUG

bupivacaine hydrochloride

0.25%locally bupivacaine hydrochloride once

Group Type PLACEBO_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Morphine Sulfate

Intervention Type DRUG

Bupivacaine Hydrochloride

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

morphine marcaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fatma Adel El sherif,MD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fatma Adel El sherif,MD

lecturer of anesthesia, ICU and pain management

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

fatma EL sherif

Role: STUDY_DIRECTOR

South Egypt Cancer Instuite, Assuit, Assuit university

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

South Egypt Cancer Instuite

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

El Sherif FA, Abd El-Rahman AM, Othman AH, Shouman SA, Omran MM, Hassan NA, Hassan SB, Aboeleuon E. Analgesic Effect of Morphine Added to Bupivacaine in Serratus Anterior Plane Block Following Modified Radical Mastectomy. Only a Local Effect? Randomized Clinical Trial. J Pain Res. 2020 Mar 31;13:661-668. doi: 10.2147/JPR.S236336. eCollection 2020.

Reference Type DERIVED
PMID: 32280268 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

348

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Speeding Recovery From Pain and Opioid Use
NCT03388814 WITHDRAWN EARLY_PHASE1
A Randomized Clinical Trial
NCT03947463 COMPLETED NA