Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery

NCT04425447 | Completed

• 1 other identifier: 33793/4/20
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecomastia; Thoracic Interfascial Plane Block; Thoracic Paravertebral Block; Anesthesia

Outcome Measures

Primary Outcomes (1)

• The amount of intraoperative fentanyl requirement (mg)

  If the patient complains from pain, fentanyl 25μg intravenously will be administrated.

  3 hours

Secondary Outcomes (1)

• Degree of patient's satisfaction

  6 hours

Other Outcomes (1)

• Amount of postoperative analgesic requirement (mg)

  24 hours

Study Arms (3)

Group C

ACTIVE COMPARATOR

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

Drug: Tumescent local anesthesia

Group TPVB

EXPERIMENTAL

30 patients will receive bilateral US guided thoracic paravertebral block.

Drug: Thoracic paravertebral block

Group TIPB

EXPERIMENTAL

30 patients will receive bilateral US guided thoracic interfascial plane block

Drug: Thoracic interfascial plane block

Interventions

Tumescent local anesthesia DRUG

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.

Group C

Thoracic paravertebral block DRUG

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.

Group TPVB

Thoracic interfascial plane block DRUG

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

Group TIPB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Gynecomastia in males only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

Location

MeSH Terms

Conditions

Gynecomastia

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: June 20, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)