Retrolaminar Thoracic Paravertebral Block

The Effect of Retrolaminar Thoracic Paravertebral Block on the Postoperative Analgesia of Patients Undergoing Breast Surgeries: Prospective Randomized Double Blinded Study

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Regional Anesthesia Morbidity
• Intervention / Treatment: Procedure: Ordinary approach paravertebral block; Procedure: Retrolaminar paravertebral block

Detailed Description

This prospective randomized controlled study will be carried out on female patients who will be presented for breast surgery in the General Surgery Department in Tanta university hospitals over 3 month duration and 6 months follow up that starts immediately after obtaining ethical committee approval, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.

Any unexpected risks that will appear during the research will be announced to the participants and to the ethical committee at time and adequate measures will be taken to resolve and avoid these risks.

Expected risks to the patients: patients enrolled in this study will have a very minimal risk of pleural puncture that will be managed by adequate observation and chest tube insertion whenever indicated. They may have a minimal risk of hypotension that will be managed by intravenous fluids and intravenous ephedrine 10 mg.

There will be adequate supervision to maintain the privacy of patients and confidentiality of data that will be used in the current study only.

There will be no conflict of interest, nor conflict with religion, law, or society standards.

The research will be beneficial to the society and has no risk of environmental pollution.

Once the patients will arrive to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached. After positioning and adequate sterilization of the back. The patients will be randomly allocated into two equal groups by the aid of computer-generated software of randomization; - • 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.

Anesthesia will be induced by fentanyl 1.5 ug/kg, propofol 1.5 mg/kg, and cis-atracurium 0.15 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to a mechanical ventilator with its parameters adjusted to maintain etCo2 34-38 mmhg. Anesthesia will be maintained by isoflurane 1.5% in mixture of oxygen:air 1:1 with the use of low flow (1 ml/min).

All the patients will be connected to a bispectral index monitor with maintaining its value ranging 40-60. Increase in the BIS value over 60 will be managed by additional dose of fentanyl 1ug/kg till decrease the BIS below 60. If the BIS is still over 60, increasing the isoflurane 0.2 % MAC till it decreased below 60.

At the end of the surgery, switching off the inhalational anesthetics, reversal of muscle relaxation, and awake tracheal extubation will be done with transporting the patients to the PACU for postoperative follow up and monitoring.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31511
    • Tanta University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ordinary approach group; 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; 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.; Other Names: thoracic paravvertebral blovk
Experimental: Retro-laminar approach group; 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; 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.; Other Names: Thoracic retrolaminar paravertebral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of complications	The incidence of complication pleural puncture, pneumothorax, hypotension, or intravascular injection .	up 24 hours from performing the technique

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Sameh Ismaiel, M.D, Lecturer of Anesthesia and Intensive Care, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2019
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): October 19, 2023

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 21, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative pain; Breast surgery; Retrolaminar; Paravertebral
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 33207/07/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Once the study had been successfully completed, the data will be shared for other researchers.

Drug and device information, study documents

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