Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery

T

Tanta University

Status

Completed

Conditions

Thoracic Interfascial Plane Block
Thoracic Paravertebral Block
Gynecomastia
Anesthesia

Treatments

Drug: Thoracic interfascial plane block
Drug: Thoracic paravertebral block
Drug: Tumescent local anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT04425447
33793/4/20

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Group C
Active Comparator group
Description:
30 patients will receive bilateral tumescent local anesthesia as a control group
Treatment:
Drug: Tumescent local anesthesia
Group TPVB
Experimental group
Description:
30 patients will receive bilateral US guided thoracic paravertebral block.
Treatment:
Drug: Thoracic paravertebral block
Group TIPB
Experimental group
Description:
30 patients will receive bilateral US guided thoracic interfascial plane block
Treatment:
Drug: Thoracic interfascial plane block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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