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

NCT ID: NCT04221074

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-07-01

Brief Summary

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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

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Conditions

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Gynecomastia, Adolescent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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 .

Group Type ACTIVE_COMPARATOR

PECS II versus ESP

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

PECS II versus ESP

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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manal mohamed rashad

lecturer of anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig university

Zagazig, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N B in gynecomastia surgery

Identifier Type: -

Identifier Source: org_study_id