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Retrolaminar Thoracic Paravertebral Block

Primary Purpose

Regional Anesthesia Morbidity, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ordinary approach paravertebral block
Retrolaminar paravertebral block
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Regional Anesthesia Morbidity focused on measuring Retrolaminar, Paravertebral, Breast surgery, Postoperative pain

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tanta University hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ordinary approach group

Retro-laminar approach group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The incidence of complications
The incidence of complication pleural puncture, pneumothorax, hypotension, or intravascular injection .

Full Information

First Posted
September 9, 2019
Last Updated
October 21, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04162951
Brief Title
Retrolaminar Thoracic Paravertebral Block
Official Title
The Effect of Retrolaminar Thoracic Paravertebral Block on the Postoperative Analgesia of Patients Undergoing Breast Surgeries: Prospective Randomized Double Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
October 19, 2023 (Actual)
Study Completion Date
October 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia Morbidity, Postoperative Pain
Keywords
Retrolaminar, Paravertebral, Breast surgery, Postoperative pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ordinary approach group
Arm Type
Experimental
Arm Description
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.
Arm Title
Retro-laminar approach group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ordinary approach paravertebral block
Other Intervention Name(s)
thoracic paravvertebral blovk
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Retrolaminar paravertebral block
Other Intervention Name(s)
Thoracic retrolaminar paravertebral block
Intervention Description
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.
Primary Outcome Measure Information:
Title
The postoperative rescue analgesia consumption
Description
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.
Time Frame
The first 24 hours postoperatively
Secondary Outcome Measure Information:
Title
The incidence of complications
Description
The incidence of complication pleural puncture, pneumothorax, hypotension, or intravascular injection .
Time Frame
up 24 hours from performing the technique

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Ismaiel, M.D
Organizational Affiliation
Lecturer of Anesthesia and Intensive Care, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University hospitals
City
Tanta
ZIP/Postal Code
31511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Once the study had been successfully completed, the data will be shared for other researchers.

Learn more about this trial

Retrolaminar Thoracic Paravertebral Block

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