TPVB, PECSB, ESPB for Postmastectmy Pain (RCT)

September 29, 2021 updated by: kareem Mikhamer, Menoufia University

A Comparative Study Between Ultrasound-guided Thoracic Paravertebral Block, Pectoral Nerves Block, and Erector Spinae Block for Pain Management in Cancer Breast Surgeries. A Randomized Controlled Study

Aim of the work The aim of the study is to compare between the effects of ultrasound guided thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management of pain during cancer breast surgeries. The hypothesis of the study is that the three groups will give comparative results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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
    • Menofia
      • Shibīn Al Kawm, Menofia, Egypt, 32511
        • Faculty of Medicine Menofia 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

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. ASA physical status classification class I or II
  2. Age group 18 - 60 years of the female gender
  3. Patients undergoing breast cancer surgeries

Exclusion Criteria:

  1. Patient refusal
  2. History of hypersensitivity to local anesthetics
  3. Bleeding disorders or patients receiving anticoagulants
  4. Spine or chest wall deformities
  5. Pregnancy
  6. Local infection at the site of injection.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group (D)
Patient will receive opioid only for management of their perioperative pain
Drug: IV morphine
given when VAS>3
Active Comparator: Paravertebral block Group (A)
Will receive thoracic paravertebral block
Drug: IV morphine
given when VAS>3
Procedure: Ultrasound guided block
Giving one regional block
Other Names:
  • Us guided paravertebral block
  • Us guided erector spinae block
  • Us guided PECs 1 and 2
Active Comparator: Pectoral block Group (B)
Will receive pectoral 1 and 2 block
Drug: IV morphine
given when VAS>3
Procedure: Ultrasound guided block
Giving one regional block
Other Names:
  • Us guided paravertebral block
  • Us guided erector spinae block
  • Us guided PECs 1 and 2
Active Comparator: Erector spinae block Group (C)
Will receive erector spinae block
Drug: IV morphine
given when VAS>3
Procedure: Ultrasound guided block
Giving one regional block
Other Names:
  • Us guided paravertebral block
  • Us guided erector spinae block
  • Us guided PECs 1 and 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).
Time Frame: 0-24o minutess
minutes
0-24o minutess

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 48 hours
assessed by VAS score (0-10) where 0=no pain and 10=worst pain
48 hours
Total morphine consumption
Time Frame: 48 hours
recorded postoperatively in mg
48 hours
Postoperative nausea and vomiting (PONV)
Time Frame: 48 hours
4 points score of PONV (0-3) where 0=no PONV and 3=vomiting more than once
48 hours

Collaborators and Investigators

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

Sponsor

Menoufia University

Investigators

  • Principal Investigator: kareem M mikhimer, m.sc, assistant fellow, Ahmed Maher Hospital

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)

April 10, 2019

Primary Completion (Actual)

August 10, 2021

Study Completion (Actual)

August 10, 2021

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32900654326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Title only

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 Pain, Postoperative

Clinical Trials on IV morphine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe