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Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery

Primary Purpose

Gynecomastia, Thoracic Interfascial Plane Block, Thoracic Paravertebral Block

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tumescent local anesthesia
Thoracic paravertebral block
Thoracic interfascial plane block
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gynecomastia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged ≥ 18 up to 65 years
  • Male gender only
  • ASA physical status I and II
  • Weight 75-100 kg
  • Duration of surgery ≤ 2 hours
  • Scheduled for elective idiopathic gynecomastia surgery

Exclusion Criteria:

  • Patient refusal.
  • Uncooperative patients.
  • Known hypersensitivity to local anesthetic (LA) (bupivacaine).
  • Local infection at the site of injection (TPVB or TIPB).
  • Coagulopathy.
  • History of opioid abuse or chronic analgesic use.

Sites / Locations

  • Tanta University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group C

Group TPVB

Group TIPB

Arm Description

30 patients will receive bilateral tumescent local anesthesia as a control group

30 patients will receive bilateral US guided thoracic paravertebral block.

30 patients will receive bilateral US guided thoracic interfascial plane block

Outcomes

Primary Outcome Measures

The amount of intraoperative fentanyl requirement (mg)
If the patient complains from pain, fentanyl 25μg intravenously will be administrated.

Secondary Outcome Measures

Degree of patient's satisfaction
Patient satisfaction before discharge using a 5- point score, with (0 = very dissatisfied, 1 = dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied).

Full Information

First Posted
June 8, 2020
Last Updated
April 19, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04425447
Brief Title
Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery
Official Title
Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block for Anesthesia in Gynecomastia Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta 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
The growing increase in the number of gynecomastia surgeries has resulted in an increased need for anesthetic techniques with improved pain reduction, safety, and fewer complications. The aim of this work is to compare the efficacy of ultrasound guided thoracic interfascial plane block and ultrasound guided thoracic paravertebral block for anesthesia in gynecomastia surgery.
Detailed Description
This prospective randomized open label clinical trial will be carried out on 90 male patients undergoing elective idiopathic gynecomastia surgery in Tanta University Hospitals. Study design: Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes: Group C: 30 patients will receive bilateral tumescent local anesthesia as a control group. Group TPVB: 30 patients will receive bilateral US guided thoracic paravertebral block. Group TIPB: 30 patients will receive bilateral US guided thoracic interfascial plane block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecomastia, Thoracic Interfascial Plane Block, Thoracic Paravertebral Block, Anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Active Comparator
Arm Description
30 patients will receive bilateral tumescent local anesthesia as a control group
Arm Title
Group TPVB
Arm Type
Experimental
Arm Description
30 patients will receive bilateral US guided thoracic paravertebral block.
Arm Title
Group TIPB
Arm Type
Experimental
Arm Description
30 patients will receive bilateral US guided thoracic interfascial plane block
Intervention Type
Drug
Intervention Name(s)
Tumescent local anesthesia
Intervention Description
Surgical disinfection of the area will be performed, skin infiltration with 2 mL of 1% lidocaine will be done, and wetting fluid will be used (1000 ml normal saline, 20 ml lidocaine 2%, and 1 mg epinephrine). Infiltration will be initiated with a 25-gauge needle. The 25-gauge needles cause little discomfort and provide enough local anesthesia to allow painless, more complete infiltration using a 20-gauge spinal needle. After the glandular nipple tissue is made somewhat tumescent, a larger (20-gauge) spinal needle can be more easily passed through the otherwise dense and resistant tissue.
Intervention Type
Drug
Intervention Name(s)
Thoracic paravertebral block
Intervention Description
The paravertebral block (PVB) will be performed in the sitting position. Surgical disinfection of the thoracic paravertebral area will be done. A linear high-frequency transducer will be used. The scanning process (longitudinal out-of-plane technique) will be started at 5 to 10 cm lateral to the spinous process to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until transverse processes are identified as more squared structure and deeper to the ribs. Once the transverse processes will be identified, skin infiltration with 2 mL of 1% lidocaine will be done. A 100-mm, 22 G needle will be inserted out of the plane to contact the transverse process and then walk off the transverse process 1 to 1.5 cm deeper searching for loss of resistance to inject 20 mL (5mL lidocaine 2% and 15 mL bupivacaine 0.25%) at each level of T4.
Intervention Type
Drug
Intervention Name(s)
Thoracic interfascial plane block
Intervention Description
Total LA injected was 80 mL (10 mL lidocaine 2% and 70 mL bupivacaine 0.25%) The linear probe will be placed below the outer third of the clavicle to detect anatomical landmarks, such as the serratus anterior muscle (SAM), external intercostal muscle (EIM), pectoralis muscles, thoracoacromial artery, and second rib. A test bolus of 1-2 ml of LA will be injected; upon confirmation of diffusion of the test dose between the external intercostal muscles and the SAM, a total of 20 ml of LA will be injected. The needle will be then carefully moved in the direction of the third and fourth ribs while confirming the expansion of the fascial plane. In the performance of the pecto-intercostal fascial plane block (PIFB), a probe will be placed parallel to the long axis of the sternum at a distance greater than 2 cm from the attachment of the second rib and sternum to identify the pectoralis muscles, EIM, and second rib. A
Primary Outcome Measure Information:
Title
The amount of intraoperative fentanyl requirement (mg)
Description
If the patient complains from pain, fentanyl 25μg intravenously will be administrated.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Degree of patient's satisfaction
Description
Patient satisfaction before discharge using a 5- point score, with (0 = very dissatisfied, 1 = dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied).
Time Frame
6 hours
Other Pre-specified Outcome Measures:
Title
Amount of postoperative analgesic requirement (mg)
Description
Postoperative pain will be assessed by numeric rating scale (NRS) score and diclofenac sodium 75 mg intramuscular will be given as rescue analgesia if NRS score was >3 (maximum 75 mg/8 hours).
Time Frame
24 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Gynecomastia in males only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥ 18 up to 65 years Male gender only ASA physical status I and II Weight 75-100 kg Duration of surgery ≤ 2 hours Scheduled for elective idiopathic gynecomastia surgery Exclusion Criteria: Patient refusal. Uncooperative patients. Known hypersensitivity to local anesthetic (LA) (bupivacaine). Local infection at the site of injection (TPVB or TIPB). Coagulopathy. History of opioid abuse or chronic analgesic use.
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
ElGharbiaa
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery

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