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

Not Applicable

Completed

• Conditions: Gynecomastia, Adolescent
• Interventions: Procedure: PECS II versus ESP

• Registration Number: NCT04221074
• Lead Sponsor: Zagazig University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-09
• Study Start: 2020-02-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Pectoral Plane (PECSII ) block (P)	PECS II versus ESP	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 .
Erector Spinae Plane ( ESP )block (E)	PECS II versus ESP	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.

Primary Outcome Measures

Name	Time	Method
intraoperative analgesia	60-120 minuets	measurement of bispectral index score

Secondary Outcome Measures

Name	Time	Method
postoperative analgesia	24 hours	total opioid consumption (mg)

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Egypt