Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery

Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block for Anesthesia in Gynecomastia Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Gynecomastia; Anesthesia; Thoracic Paravertebral Block; Thoracic Interfascial Plane Block
• Intervention / Treatment: Drug: Tumescent local anesthesia; Drug: Thoracic paravertebral block; Drug: Thoracic interfascial plane block

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • ElGharbiaa
    • Tanta, ElGharbiaa, Egypt, 31527
      • Tanta University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group C; 30 patients will receive bilateral tumescent local anesthesia as a control group	Drug: 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.
Experimental: Group TPVB; 30 patients will receive bilateral US guided thoracic paravertebral block.	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.
Experimental: Group TIPB; 30 patients will receive bilateral US guided thoracic interfascial plane block	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of intraoperative fentanyl requirement (mg)	If the patient complains from pain, fentanyl 25μg intravenously will be administrated.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of postoperative analgesic requirement (mg)	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).	24 hours

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Breast Diseases; Aneurysm; Gynecomastia; Aneurysm, Dissecting; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 33793/4/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No