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

Gynecomastia, Adolescent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04221074
• Other study ID #: N B in gynecomastia surgery
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: December 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gynecomastia
• Gynecomastia, Adolescent

Intervention

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

Locations

Country	Name	City	State
Egypt	Zagazig university	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative analgesia	measurement of intraoperative mean blood pressure (mmHg)	60-120 minuets
Primary	intraoperative analgesia	measurement of heart rate (beat /min)	60-120 minuets
Primary	intraoperative analgesia	measurement of bispectral index score	60-120 minuets
Secondary	postoperative analgesia	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.	24 hours
Secondary	postoperative analgesia	time interval till first analgesic request (minuets)	24 hours
Secondary	postoperative analgesia	total opioid consumption (mg)	24 hours