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

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

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.

Study Overview

• Status: Completed
• Conditions: Gynecomastia, Adolescent
• Intervention / Treatment: Procedure: PECS II versus ESP

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Modified Pectoral Plane (PECSII ) block (P); done after induction of general anaesthesia in supine position of the patient with his arm of the side of the operation abducted 90 degree with the probe with frequency L4-12t (Logiq e machine) at the midclavicular level and angled infero-laterally,the axillary artery and vein and the second rib identified the probe moved laterally until the pectoralis minor and serratus anterior are identified,the local anesthetic was injected at two points using (echoplext guge20 length 50 mm ) needle:the first injection of 10 ml of 0.25% Bupivacaine and 4 mg dexamethasone injected between the pectoralis major and minor muscles,and the second injection of 20 ml of 0.25% Bupivacaine and 4 mg dexamethasone between the pectoralis minor and serratus anterior muscles .	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.
ACTIVE_COMPARATOR: Erector Spinae Plane ( ESP )block (E); after induction of general anaesthesia in lateral position of the patient where the surgical side up and at T4 level the probe with frequency L4-12t (Logiq e machine) placed lateral to the spine by 3 cm in parasagittal plane the needle (echoplext guge20 length 50 mm ) advanced between the transverse process and the erector spinae muscle at that level 20 ml of 0.25% Bupivacaine and 8 mg dexamethasone injected.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative analgesia	measurement of intraoperative mean blood pressure (mmHg)	60-120 minuets
intraoperative analgesia	measurement of heart rate (beat /min)	60-120 minuets
intraoperative analgesia	measurement of bispectral index score	60-120 minuets

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
postoperative analgesia	time interval till first analgesic request (minuets)	24 hours
postoperative analgesia	total opioid consumption (mg)	24 hours

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2020
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (ACTUAL): January 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Gynecomastia
• Other Study ID Numbers: N B in gynecomastia surgery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No