Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery

NCT ID: NCT04425447

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-20
• Study Completion Date: 2021-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group C

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

Group Type: ACTIVE_COMPARATOR

Tumescent local anesthesia

Intervention Type: 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 TPVB

30 patients will receive bilateral US guided thoracic paravertebral block.

Group Type: EXPERIMENTAL

Thoracic paravertebral block

Intervention Type: 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 TIPB

30 patients will receive bilateral US guided thoracic interfascial plane block

Group Type: EXPERIMENTAL

Thoracic interfascial plane block

Intervention Type: 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

Interventions

Tumescent local anesthesia

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

Thoracic paravertebral block

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

Thoracic interfascial plane block

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Taysser Mahmoud Abdalraheem

Principal Investigator - Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospitals

Tanta, ElGharbiaa, Egypt

Countries

Egypt

Other Identifiers

33793/4/20

Identifier Type: -

Identifier Source: org_study_id