Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery

December 12, 2017 updated by: Khaled Mostafa Kamel, Cairo University

A Comparative Study for Evaluation of the Analgesic Profile of Ultrasound-Guided Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery

The purpose of this study is to compare the analgesic profile of modified pectoral nerves block and serratus plane block in patients undergoing mastectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study includes three groups. The first group will receive ultrasound-guided modified pectoral nerves block prior to induction of general anesthesia. The second one will receive ultrasound-guided serratus plane block prior to induction of general anesthesia. The third one will not receive any block preoperatively.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

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
    • Misr Al Qadimah
      • Cairo, Misr Al Qadimah, Egypt, 11796
        • National Cancer Institute

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • American Society of Anesthesiologists( ASA) I or II and scheduled for major breast cancer surgery( modified radical mastectomy or conservative mastectomy with axillary evacuation).

Exclusion Criteria:

  • Local infection at the site of the block, coagulations abnormalities, allergy to local anesthetics or morphine, body mass index> 35, patient refusal, severe respiratory or cardiac disorders, pre-existing neurological deficits, hepatic or renal insufficiency, chronic pain syndrome, chronic analgesic use and psychiatric disorders.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: modified pectoral nerves block
Modified pectoral nerves block with general anesthesia. Using the ultrasound, 10 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis major and minor muscles. And another 20 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis minor and the serratus anterior muscles.
Drug: Bupivacaine 0.25% with epinephrine
Other Names:
  • Markyrene
Active Comparator: serratus plane block
Serratus plane block with general anesthesia. Using the ultrasound, 0.4 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the serratus anterior muscle and the underlying ribs.
Drug: Bupivacaine 0.25% with epinephrine
Other Names:
  • Markyrene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fentanyl consumption
Time Frame: Intraoperative
Intraoperative
Total morphine consumption
Time Frame: The first 24 hours postoperative
The first 24 hours postoperative
Visual analogue scale score at rest and during shoulder movement
Time Frame: The first 24 hours postoperative
The first 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial blood pressure
Time Frame: Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative
Hemodynamics
Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative
Heart rate
Time Frame: Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative
Hemodynamics
Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative
Time to first requirement of rescue analgesia
Time Frame: The first 24 hours postoperative
The first 24 hours postoperative
Sedation score
Time Frame: Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative
as a side effect of morphine
Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative
Respiratory rate
Time Frame: Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative
respiratory depression defined as respiratory rate <12 breaths per minute
Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative
Nausea and vomiting
Time Frame: The first 24 hours postoperative
as a side effect of morphine
The first 24 hours postoperative
Patient satisfaction with postoperative analgesia
Time Frame: One week after surgery
using numerical rating scale from 0 to 10
One week after surgery

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Ayman A Ghoneim, MD, National Cancer Institute, Cairo University
  • Study Chair: Ahmad H Aboul Soud, MD, National Cancer Institute, Cairo University
  • Principal Investigator: Khaled M Salem, Master, National Cancer Institute, Cairo University
  • Principal Investigator: Mohamed E Hassan, MD, National Cancer Institute, Cairo University
  • Principal Investigator: Ahmad H Mohamed, MD, National Cancer Institute, Cairo 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

October 1, 2016

Primary Completion (Actual)

December 4, 2017

Study Completion (Actual)

December 11, 2017

Study Registration Dates

First Submitted

October 23, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD2010014055.3
  • IRB00004025 (Other Identifier: National Cancer Institute Cairo university)

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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