Retrolaminar Thoracic Paravertebral Block

NCT04162951 | Completed

• 1 other identifier: 33207/07/19
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study will be conducted on female patients admitted to The General Surgery Department of Tanta Faculty of Medicine for a period of 9 months. Patients will be randomly allocated into one of the following two groups;- • Ordinary approach group (30 patients): The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block. • Retro-laminar approach group (30 patients): The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block. All the patients will receive general anesthesia with attachment to a monitor (5 ASA Monitoring) In addition to bispectral index.

Conditions

Regional Anesthesia Morbidity; Postoperative Pain

Keywords

Retrolaminar; Paravertebral; Breast surgery; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• The postoperative rescue analgesia consumption

  Morphine consumption in the first 24 h postoperatively (3 mg morphine i.v will be given when the postoperative VAS score was 4 or more considering the total dose consumption in the first postoperative day not exceeding 15 mg.

  The first 24 hours postoperatively

Secondary Outcomes (1)

• The incidence of complications

  up 24 hours from performing the technique

Study Arms (2)

Ordinary approach group

EXPERIMENTAL

The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block. by local anesthetic mixture at a volume of 0.2 ml/kg composed of plain bupivacaine 0.25% and Fentanyl 2 ug/ml.

Procedure: Ordinary approach paravertebral block

Retro-laminar approach group

EXPERIMENTAL

The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block by local anesthetic mixture at a volume of 0.2 ml/kg composed of plain bupivacaine 0.25% and Fentanyl 2 ug/ml.

Procedure: Retrolaminar paravertebral block

Interventions

Ordinary approach paravertebral block PROCEDURE

Ultrasound guided thoracic paravertebral block. At the appropriate dermatome, the needle (22-gauge, 8-10-cm, short bevelled spinal needle, or a Touhy needle if a catheter is to be placed) is inserted 2.5-3 cm lateral to the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process at a variable depth (2-4 cm) depending on the build of the individual. The needle is then walked above the transverse process and gradually advanced until a loss of resistance to air or saline, or a subtle 'click' is felt as the superior costotransverse ligament is penetrated, usually within 1-1.5 cm from the superior edge of the transverse process.

Also known as: thoracic paravvertebral blovk

Ordinary approach group

Retrolaminar paravertebral block PROCEDURE

In the retrolaminar approach to TPVB or retrolaminar block (RB), local anesthetic (LA) is injected into the retrolaminar plane to achieve a truncal sensory block like that of traditional TPVB. It has been postulated that during RB, LA spreads from the injection plane to the thoracic paravertebral space (TPVS) through the superior costotransverse ligament (SCTL). Retrolaminar block will be performed under ultrasound guidance, as a single injection.

Also known as: Thoracic retrolaminar paravertebral block

Retro-laminar approach group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients
• Aged 40-60 years
• ASA class I-II.
• Presented for elective breast surgery.

You may not qualify if:

• Patients refused to participate
• Patients with known or suspected or known allergy to the used medication.
• Patients with spinal deformities.
• Patients with preoperative chronic pain,
• Patients received preoperative opioids or gabapentoids.
• Patients with major cardiac, renal, respiratory, or hepatic disease.
• Patients with suspected or diagnosed coagulopathy
• Uncooperative patients.
• Obese patients with BMI \>36

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sameh Ismaiel, M.D

  Lecturer of Anesthesia and Intensive Care, Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants and the investigator will be kept blinded by the aid of closed sealed envelops. The measurements will be collected by the aid of assistant resident who will not participating into the study and blinded to it.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Prospective study

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: November 14, 2019
• Study Start: November 10, 2019
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)