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Completed

NCT Number: NCT04221074

Ultrasound Guided Modified Pectoral Plane Block Versus Erector Spinae Plane Block During GA in Gynecomastia Surgery

Pain of breast surgery is due to chest wall scar and arm in some cases like carcinoma or due to nerve injury.It is neuropathic or nociceptive pain.Its severity is depending on the extent of surgery and the radiotherapy if needed.

Previous studies proved that local nerve block procedures improved the immediate postoperative pain and decreased the incidence of postoperative pain chronicity .

Also effective control of pain suppresses the surgical stress response minimizes the anaesthestic needs intraoperatively and decreases the opioid needs postoperatively .

Pectoralis nerve(pecs) II block and erector spinae plane (ESP) block are novel procedures that may provide good intraoperative and postoperative analgesia in patients undergoing surgical treatment of gynecomastia.

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Key information

Conditions

Gynecomastia, Adolescent Breast Diseases Gynecomastia Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university

Zagazig, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male gender .
  • Age : 18 - 25 years old .
  • Physical status : ASA I - II .
  • Body mass index(BMI) :20-30 kg/m2
  • Surgical treatment of Gynecomastia .
  • Duration of surgery : 60 -120 min

Exclusion criteria

  • Patient refusal .
  • History of opioid abuse or chronic analgesic use .
  • Coagulopathy .
  • Allergy to study drugs .
  • Infection in the injection sites.
  • Uncooperative patients.

Treatment and study plan

PECS II versus ESP

Procedure

compare between :ultrasound guided Pectoralis nerve(pecs) II block or erector spinae plane (ESP) block in surgical treatment for gynecomastia patients under general anaesthesia.

Primary outcomes

  1. intraoperative analgesia

    Time frame: 60-120 minuets

    measurement of intraoperative mean blood pressure (mmHg)

  2. intraoperative analgesia

    Time frame: 60-120 minuets

    measurement of heart rate (beat /min)

  3. intraoperative analgesia

    Time frame: 60-120 minuets

    measurement of bispectral index score

Secondary outcomes

  1. postoperative analgesia

    Time frame: 24 hours

    evaluation of postoperative visual analogue scaleusing a ruler graded from 0 to 100 mm,where 0=no pain and 100=the worst imaginable pain measured in postanaesthesia care unit and every 6hours for 24 h postoperative.

  2. postoperative analgesia

    Time frame: 24 hours

    time interval till first analgesic request (minuets)

  3. postoperative analgesia

    Time frame: 24 hours

    total opioid consumption (mg)

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Ultrasound Guided Modified Pectoral Plane (PECS II )Block Versus Erector Spinae Plane (ESP) Block for Perioperative Analgesia of Surgical Treatment of Gynecomastia

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2020
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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