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Efficacy of Serratus Anterior Plane Block Mastectomy

Primary Purpose

Postoperative Pain, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
serratus anterior plan block
Sponsored by
doaa rashwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty Of Medicine, Beni-Suef University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

GBM:( bupivacaine/magnesium sulphate)

GBN: ( bupivacaine/nalpuphin)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

time to first analgesic requirements in minutes
time to first analgesic requirements in minutes by the patient

Secondary Outcome Measures

Full Information

First Posted
May 6, 2019
Last Updated
February 11, 2020
Sponsor
doaa rashwan
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1. Study Identification

Unique Protocol Identification Number
NCT03944759
Brief Title
Efficacy of Serratus Anterior Plane Block Mastectomy
Official Title
Efficacy of Serratus Anterior Plane Block Using Bupivacaine/Magnesium Sulphate Versus Bupivacaine/Nalbuphine for Mastectomy: a Randomized Double Blinded Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
doaa rashwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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 .
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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GBM:( bupivacaine/magnesium sulphate)
Arm Type
Active Comparator
Arm Description
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
Arm Title
GBN: ( bupivacaine/nalpuphin)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
serratus anterior plan block
Intervention Description
serratus anterior plan block
Primary Outcome Measure Information:
Title
time to first analgesic requirements in minutes
Description
time to first analgesic requirements in minutes by the patient
Time Frame
change from base line for 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doaa Rashwan, MD
Organizational Affiliation
Faculty of Medicine Beni-Suef University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty Of Medicine, Beni-Suef University
City
Banī Suwayf
ZIP/Postal Code
11391
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
the protocol
IPD Sharing Time Frame
after registration for ever
IPD Sharing Access Criteria
on the web page -

Learn more about this trial

Efficacy of Serratus Anterior Plane Block Mastectomy

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