TPVB, PECSB, ESPB for Postmastectmy Pain

NCT05076773 | Completed

• 1 other identifier: 32900654326
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).

  minutes

  0-24o minutess

Secondary Outcomes (3)

• Postoperative pain

  48 hours

• Total morphine consumption

  48 hours

• Postoperative nausea and vomiting (PONV)

  48 hours

Study Arms (4)

Control Group (D)

PLACEBO COMPARATOR

Patient will receive opioid only for management of their perioperative pain

Drug: IV morphine

Paravertebral block Group (A)

ACTIVE COMPARATOR

Will receive thoracic paravertebral block

Procedure: Ultrasound guided block; Drug: IV morphine

Pectoral block Group (B)

ACTIVE COMPARATOR

Will receive pectoral 1 and 2 block

Procedure: Ultrasound guided block; Drug: IV morphine

Erector spinae block Group (C)

ACTIVE COMPARATOR

Will receive erector spinae block

Procedure: Ultrasound guided block; Drug: IV morphine

Interventions

Ultrasound guided block PROCEDURE

Giving one regional block

Also known as: Us guided paravertebral block, Us guided erector spinae block, Us guided PECs 1 and 2

Erector spinae block Group (C); Paravertebral block Group (A); Pectoral block Group (B)

IV morphine DRUG

given when VAS\>3

Control Group (D); Erector spinae block Group (C); Paravertebral block Group (A); Pectoral block Group (B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patient refusal
• History of hypersensitivity to local anesthetics
• Bleeding disorders or patients receiving anticoagulants
• Spine or chest wall deformities
• Pregnancy
• Local infection at the site of injection.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine Menofia University

Shibīn al Kawm, Menofia, 32511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• kareem M mikhimer, m.sc

  assistant fellow, Ahmed Maher Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant fellow

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 13, 2021
• Study Start: April 10, 2019
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)