Gynecomastia, AdolescentNCT04221074

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

A study testing PECS II versus ESP in people with Gynecomastia, Adolescent, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 25 years, men onlyHealthy volunteers can take part
Conditions the study is for: Gynecomastia, Adolescent
What is being tested?: PECS II versus ESP
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteEgypt
Study dates: 1 Feb 2020to 1 Jul 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Zagazig university
Zagazig

Other trials in Egypt

About this study

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

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.

Conditions: Gynecomastia, Adolescent
Being tested: PECS II versus ESP
Medical subject headings: Gynecomastia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04221074
Study group	Role	What they receive
Modified Pectoral Plane (PECSII ) block (P)	Active comparator	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 . Receives: Procedure: PECS II versus ESP
Erector Spinae Plane ( ESP )block (E)	Active comparator	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. Receives: Procedure: PECS II versus ESP

What is being measured

The primary outcome is the main question the study is designed to answer.

intraoperative analgesia
measurement of intraoperative mean blood pressure (mmHg)
Measured: 60-120 minuets
intraoperative analgesia
measurement of heart rate (beat /min)
Measured: 60-120 minuets
intraoperative analgesia
measurement of bispectral index score
Measured: 60-120 minuets

Secondary outcomes (3)

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.
Measured: 24 hours
postoperative analgesia
time interval till first analgesic request (minuets)
Measured: 24 hours
postoperative analgesia
total opioid consumption (mg)
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20201 Jul 2020

First posted9 Jan 2020
Study start1 Feb 2020
Primary completion1 Jun 2020
Study completion1 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gynecomastia, AdolescentStudies of the same condition, open and under way.
More trials run by Zagazig UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04221074
Sponsor's protocol ID: N B in gynecomastia surgery
Status last verified: Dec 2020
First submitted: 6 Jan 2020
Last updated: 14 Dec 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound Guided Modified Pectoral Plane (PECS II )Block Versus Erector Spinae Plane (ESP) Block for Perioperative Analgesia of Surgical Treatment of Gynecomastia
ClinicalTrials.gov ID: NCT04221074
Acronym / sponsor ID: N B in gynecomastia surgery
Conditions: Gynecomastia, Adolescent
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Zagazig UniversityOther government
Study start: 1 Feb 2020 (actual)
Primary completion: 1 Jun 2020 (actual)
Study completion: 1 Jul 2020 (actual)
First posted: 9 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 .

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2

Arm	Type	Receives
Modified Pectoral Plane (PECSII ) block (P)	Active comparator	Procedure: PECS II versus ESPdone 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)	Active comparator	Procedure: PECS II versus ESPafter 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.

Who may qualify

Ages: 18 to 25 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PECS II versus ESPcompare between :ultrasound guided Pectoralis nerve(pecs) II block or erector spinae plane (ESP) block in surgical treatment for gynecomastia patients under general anaesthesia.	Procedure or surgery	Erector Spinae Plane ( ESP )block (E), Modified Pectoral Plane (PECSII ) block (P)

Primary outcome

intraoperative analgesia
Time frame: 60-120 minuets
measurement of intraoperative mean blood pressure (mmHg)
intraoperative analgesia
Time frame: 60-120 minuets
measurement of heart rate (beat /min)
intraoperative analgesia
Time frame: 60-120 minuets
measurement of bispectral index score

3 secondary outcomes

postoperative analgesia
Time frame: 24 hours
postoperative analgesia
Time frame: 24 hours
postoperative analgesia
Time frame: 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PECS II versus ESP in people with Gynecomastia, Adolescent, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intraoperative analgesia (time frame: 60-120 minuets). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04221074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.