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

Primary Purpose

Gynecomastia, Adolescent

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PECS II versus ESP
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecomastia, Adolescent

Eligibility Criteria

18 Years - 25 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Zagazig university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Modified Pectoral Plane (PECSII ) block (P)

Erector Spinae Plane ( ESP )block (E)

Arm Description

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 .

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.

Outcomes

Primary Outcome Measures

intraoperative analgesia
measurement of intraoperative mean blood pressure (mmHg)
intraoperative analgesia
measurement of heart rate (beat /min)
intraoperative analgesia
measurement of bispectral index score

Secondary Outcome Measures

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

Full Information

First Posted
January 6, 2020
Last Updated
December 10, 2020
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04221074
Brief Title
Ultrasound Guided Modified Pectoral Plane Block Versus Erector Spinae Plane Block During GA in Gynecomastia Surgery
Official Title
Ultrasound Guided Modified Pectoral Plane (PECS II )Block Versus Erector Spinae Plane (ESP) Block for Perioperative Analgesia of Surgical Treatment of Gynecomastia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecomastia, Adolescent

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Pectoral Plane (PECSII ) block (P)
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Erector Spinae Plane ( ESP )block (E)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PECS II versus ESP
Intervention Description
compare between :ultrasound guided Pectoralis nerve(pecs) II block or erector spinae plane (ESP) block in surgical treatment for gynecomastia patients under general anaesthesia.
Primary Outcome Measure Information:
Title
intraoperative analgesia
Description
measurement of intraoperative mean blood pressure (mmHg)
Time Frame
60-120 minuets
Title
intraoperative analgesia
Description
measurement of heart rate (beat /min)
Time Frame
60-120 minuets
Title
intraoperative analgesia
Description
measurement of bispectral index score
Time Frame
60-120 minuets
Secondary Outcome Measure Information:
Title
postoperative analgesia
Description
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.
Time Frame
24 hours
Title
postoperative analgesia
Description
time interval till first analgesic request (minuets)
Time Frame
24 hours
Title
postoperative analgesia
Description
total opioid consumption (mg)
Time Frame
24 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Zagazig university
City
Zagazig
Country
Egypt

12. IPD Sharing Statement

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

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