Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery

Not Applicable

Completed

• Conditions: Thoracic Paravertebral Block; Anesthesia; Gynecomastia; Thoracic Interfascial Plane Block
• Interventions: Drug: Tumescent local anesthesia; Drug: Thoracic interfascial plane block; Drug: Thoracic paravertebral block

• Registration Number: NCT04425447
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-11
• Study Start: 2020-06-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Tumescent local anesthesia	30 patients will receive bilateral tumescent local anesthesia as a control group
Group TIPB	Thoracic interfascial plane block	30 patients will receive bilateral US guided thoracic interfascial plane block
Group TPVB	Thoracic paravertebral block	30 patients will receive bilateral US guided thoracic paravertebral block.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Degree of patient's satisfaction	6 hours	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).

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, ElGharbiaa, Egypt