Efficacy of Serratus Anterior Plane Block Mastectomy

February 11, 2020 updated by: doaa rashwan

Efficacy of Serratus Anterior Plane Block Using Bupivacaine/Magnesium Sulphate Versus Bupivacaine/Nalbuphine for Mastectomy: a Randomized Double Blinded Comparative Study

Breast cancer is the main common cancer among females. . Inadequate control of pain may later develop into chronic pain syndrome (paraesthesias, phantom breast pain, and intercostobrachial neuralgia) in 25-40% of the patients .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to compare the efficacy of ultrasound-guided serratus anterior plane block with bupivacaine/ magnesium versus bupivacaine/ nalbuphine in breast cancer surgery.

Patients and methods nclusion criteria:

-ASA I and II female patients, age 25-60 undergoing breast cancer surgery

Exclusion criteria:

  • Patient refusal
  • Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
  • Allergy to the drugs used in the study
  • Chronic pain therapy,
  • BMI more than 30 kg/m2

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
      • Banī Suwayf, Egypt, 11391
        • Faculty of Medicine, Beni-suef University

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

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I and II female patients, age 25-60 undergoing breast cancer surgery

Exclusion Criteria:

  • -Patient refusal
  • Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
  • Allergy to the drugs used in the study
  • Chronic pain therapy,
  • BMI more than 30 kg/m2

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: GBM:( bupivacaine/magnesium sulphate)

serratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia.

GBM:( bupivacaine/magnesium sulphate): will receive bupivacaine 30 ml 0.25 and 500 mg magnesium sulphate
Procedure: serratus anterior plan block
serratus anterior plan block
ACTIVE_COMPARATOR: GBN: ( bupivacaine/nalpuphin)
serratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia.. ( bupivacaine/nalpuphin):received bupivacaine 30 ml 0.25 % and nalpuphine 0.2mg/kg.
Procedure: serratus anterior plan block
serratus anterior plan block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to first analgesic requirements in minutes
Time Frame: change from base line for 24 hours
time to first analgesic requirements in minutes by the patient
change from base line for 24 hours

Collaborators and Investigators

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

Sponsor

doaa rashwan

Investigators

  • Study Director: Doaa Rashwan, MD, Faculty of Medicine Beni-Suef University

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 (ACTUAL)

May 7, 2019

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (ACTUAL)

May 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSURECS/30042019/Ali

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the protocol

IPD Sharing Time Frame

after registration for ever

IPD Sharing Access Criteria

on the web page

-

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Postoperative Complications

Clinical Trials on serratus anterior plan block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe